CARDIOVASCULAR
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AMPLATZER™ HEART OCCLUDERS

Through non-clinical testing, Amplatzer™ devices have been shown to be MR Conditional. Optimal scanning conditions vary among products. We have included some guidelines here, but please refer to each product’s Instructions for Use for further details.**

MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of the implant.

AMPLATZER™ SEPTAL OCCLUDER
  • MR Conditional to 3.0 Tesla

Caution should be used if an MRI is performed with a magnetic field of >3.0 tesla.

Through non-clinical testing, the AMPLATZER™ device has been known to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.0 tesla for a 20-minute exposure to a B1 of 118 μT. The AMPLATZER™ device should not migrate in this MR environment. Non-clinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.

In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla.

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

AMPLATER™ SEPTAL OCCLUDER MULTI-FENESTRATED
  • MR Conditional to 3.0 Tesla

Caution should be used if an MRI is performed with a magnetic field of >3.0 tesla. Through non-clinical testing, the AMPLATZER™ device has been known to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.0 tesla for a 20-minute exposure to a B1 of 118 μT. The AMPLATZER™ device should not migrate in this MR environment. Non-clinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.

In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla. MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

AMPLATER™ DUCT OCCLUDER
  • MR Conditional to 3.0 Tesla

Through nonclinical testing, the AMPLATZER™ device has been known to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.0 tesla for a 20-minute exposure to a B1 of 118μ tesla. The AMPLATZER™ device should not migrate in this MR environment. Nonclinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.

In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla. MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

AMPLATER™ DUCT OCCLUDER II

MR Conditional
St. Jude Medical’s AMPLATZER™ Duct Occluder II device is manufactured of chemically etched nitinol wire, 80% platinum 20% iridium marker band and a 316L end screw.

Non-clinical testing has demonstrated that the AMPLATZER™ Duct Occluder II device is MR-Conditional. Patients can be scanned safely immediately after implantation under the following conditions:

  • Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T)
  • Maximum spatial gradient field less than or equal to 30 T/m
  • Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning

In non-clinical testing with body coil excitation, the AMPLATZER™ Duct Occluder II device produced a differential temperature rise of less than or equal to 3.65ºC when exposed to a maximum average whole body specific absorption rate (SAR) of 3.35 W/kg for 15 minutes of scanning in a 3.0-Tesla MR system (Siemens MAGNETOM Trio™, SYNGO™ MR A35 4VA35A software, Erlangen, Germany). Scaling of the SAR and observed heating indicates that average whole body SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than or equal to 1.0ºC in Normal Operating Mode.

In non-clinical testing with body coil excitation, the AMPLATZER™ Duct Occluder II device produced a differential temperature rise of less than or equal to 1.91ºC when exposed to a maximum average whole body specific absorption rate (SAR) of 2.80 W/kg for 15 minutes of scanning in a 1.5-Tesla MR system (Siemens MAGNETOM Espree™, SYNGO™ MR B17 software, Erlangen, Germany).Scaling of the SAR and observed heating indicates that average whole body SAR of 2.0W/kg would be expected to yield a localized temperature rise of less than or equal to approximately 1.0 ºC in Normal Operating Mode.

MR image quality may be compromised if the area of interest is the same or relatively close to the position of the device. Therefore, it may be necessary to optimize the MR imaging parameters for the presence of this implant.

AMPLATZER™ PFO OCCLUDER

MR Conditional
Non-clinical testing has demonstrated the Amplatzer™ device is MR Conditional. A patient with an implanted Amplatzer™ device can be scanned safely in an MR system under the following conditions:

  • Static magnetic field of 1.5 tesla or 3 tesla
  • Spatial gradient magnetic field of 720 G/cm or less
  • Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above the Amplatzer™ device is expected to produce a maximum temperature rise of less than 2.5 °C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 0.9 cm from the implant when imaged with a gradient echo pulse sequence and a 3.0T MRI system and 0.6 cm when imaged with a gradient echo pulse sequence and a 1.5T MRI system.

AMPLATZER PICCOLO™ OCCLUDER

MR Conditional
Non-clinical testing has demonstrated the AMPLATZER™ PFO Occluder is MR Conditional. It can be scanned safely under the following conditions:

  • Static magnetic field of 1.5 Tesla or 3.0 Tesla
  • Maximum spatial gradient field less than or equal to 30 T/m
  • Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning

In non-clinical testing the AMPLATZER™ PFO Occluder device produced a temperature rise of less than or equal to 1.79° C at a maximum whole-body averaged specific absorption rate (SAR) of 3.4 W/kg for 15 minutes of MR scanning in a 3.0 Tesla MR system (Siemens™ MAGNETOM Trio™, SYNGO™ MR A35 4VA35A software, Erlangen, Germany).

In non-clinical testing the AMPLATZER™ PFO Occluder device produced a temperature rise of less than or equal to 1.61° C at a maximum whole-body averaged specific absorption rate (SAR) of 2.9 W/kg for 15 minutes of MR scanning in a 1.5 Tesla MR system (Siemens™ MAGNETOM Espree™, SYNGO™ MR B17 software, Erlangen, Germany).

MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant.

AMPLATZER™ MUSCULAR VSD OCCLUDER

MR Conditional
Through non-clinical testing, AMPLATZER™ devices have been shown to be MR Conditional. A patient with an implanted AMPLATZER™ device can be scanned safely immediately after placement of the device under the following conditions:

  • Static magnetic field of 3 tesla or less
  • Spatial gradient magnetic field of 720 G/cm or less
  • Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

During testing, the device produced a clinically non-significant temperature rise at a maximum MR system-reported, whole body- averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning in a 3-tesla MR system using a transmit/receive body coil.

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

AMPLATZER™ POST-INFARCT MUSCULAR VSD OCCLUDER

MR Safety Information
Non-clinical testing has demonstrated the AMPLATZER™ Post-Infarct Muscular VSD Occluder is MR Conditional. A patient with this device can be safely scanned immediately after implantation in an MR system meeting the following conditions:

  • Static magnetic field of 3T
  • Maximum spatial field gradient of 720 gauss/cm
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, the AMPLATZER™ Post-Infarct Muscular VSD Occluder is expected to produce a maximum temperature rise of less than 1.7ºC after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 20 mm from the AMPLATZER™ Post-Infarct Muscular VSD Occluder when imaged with a gradient echo pulse sequence and a 3T MRI system.

MECHANICAL HEART VALVES

Heart Valves and Repair Devices MRI Safety Information

REGENT™ MECHANICAL HEART VALVE

Models

xxAGN-751

xxAGFN-756

xx denotes different sizes available (e.g. 19 AGFN-751).

Non-clinical testing has demonstrated that these Abbott mechanical heart valves are MR Conditional. Patients can be scanned safely immediately after implantation under the following conditions: 

  • Static magnetic field of 1.5 Tesla (T) or 3.0 T
  • Maximum spatial gradient field less than or equal to 3,000 Gauss/cm (30 T/m)
  • Normal Operating Mode: Maximum whole-body-averaged specific absorption rate (SAR) of: 
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5 T
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0 T

3.0 T RF heating

In non-clinical testing with body coil excitation, the Abbott Regent™ mechanical heart valves produced a differential temperature rise of less than or equal to 1.0˚C when exposed to a whole-body SAR of 3.1 W/kg for 15 minutes of scanning in a 3.0 T MR system (Siemens MAGNETOM Trio, SYNGO MR A30 4VA30A software, Munich, Germany). Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than 1.0˚C.

1.5 T RF heating

In non-clinical testing with body coil excitation, the Abbott Regent™ mechanical heart valves produced a differential temperature rise of less than or equal to 1.0˚C when exposed to a whole-body SAR of 1.0 W/kg for 15 minutes of scanning in a 1.5 T MR system (Siemens MAGNETOM Espree, SYNGO MR B17 software, Munich, Germany). Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than 1.0˚C.

Caution: The RF heating behavior does not scale with static field strength. Devices which do not exhibit detectable heating at one field strength may exhibit high values of localized heating at another heating field strength.

MR Artifacts

MR image quality may be compromised if the area of interest is the same or relatively close to the position of the device, and it may be necessary to optimize the MR imaging parameters. The shape of the expected artifact follows the approximate contour of the device and extends radially up to 0.7 cm from the implant at 3.0 T in spin echo imaging and 0.8 cm at 1.5 T in gradient echo imaging tests performed in accordance with ASTM F2119-07.

ABBOTT STANDARD AND MASTERS SERIES MECHANICAL HEART VALVES AND VALVED GRAFTS

Models

xxA-101

xxM-101

xxAJ-501

xxMJ-501

xxAVG-201

xxAEC-102

xxMEC-102

xxAECJ-502

xxMECJ-502

xxPVG-201

xxAT-103

xxMT-103

xxATJ-503

xxMTJ-503

xxSAVG-301

xxAET-104

xxMET-104M

xxAETJ-504

xxMETJ-504

xxCAVG-404

xxAHP-105

xxMHP-105

xxAHPJ-505

xxMHPJ-505

xxCAVGJ-514

   

xxAEHPJ-505

xxMEHPJ-505

xxCAVGJ-514 00

   

xxAFHPJ-505

 

xxVAVGJ-505

xx denotes different sizes available (e.g. 19A-101).

Non-clinical testing has demonstrated that these Abbott mechanical heart valves and valved grafts are MR Conditional. Patients can be scanned safely immediately after implantation under the following conditions: 

  • Static magnetic field of 1.5 Tesla (T) or 3.0 T
  • Maximum spatial gradient field less than or equal to 3,000 Gauss/cm (30 T/m)
  • Normal Operating Mode: Maximum whole-body-averaged specific absorption rate (SAR) of: 
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5 T
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0 T

3.0 T RF heating

In non-clinical testing with body coil excitation, the Abbott mechanical heart valves and valved grafts produced a differential temperature rise of less than or equal to 1.0˚C when exposed to a whole-body SAR of 3.4 W/kg for 15 minutes of scanning in a 3.0 T MR system (Siemens MAGNETOM Trio‡, SYNGO‡ MR A30 4VA30A software, Munich, Germany). Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than 1.0˚C.

1.5 RF heating

In non-clinical testing with body coil excitation, Abbott mechanical heart valves and valved grafts produced a differential temperature rise of less than or equal to 1.0˚C when exposed to a whole-body SAR of 1.4 W/kg for 15 minutes of scanning in a 1.5 T MR system (Siemens MAGNETOM Espree, SYNGO MR B17 software, Munich, Germany). Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than 2.0˚C.

Caution: The RF heating behavior does not scale with static field strength. Devices which do not exhibit detectable heating at one field strength may exhibit high values of localized heating at another heating field strength.

MR Artifacts

MR image quality may be compromised if the area of interest is the same or relatively close to the position of the device, and it may be necessary to optimize the MR imaging parameters. The shape of the expected artifact follows the approximate contour of the device and extends radially up to 1.4 cm from the implant at 3.0 T and 1.1 cm at 1.5 T in gradient echo imaging tests performed in accordance with ASTM F2119-07.

TISSUE VALVES

Heart Valves and Repair Devices MRI Safety Information

BIOCOR™ AND EPIC™ HEART VALVES

Models

B10-xxA

B100-xxA

EL-xxA

E100-xxA

B10-xxA-00

B100-xxA-00

EL-xxM

E100-xxA-00

B10-xxM-

B100-xxM

ESP-xx

E100-xxM

B10-xxM-00

B100-xxM-00

 

E100-xxM-00

B10SP-xx

BSP100-xx

 

ESP100-xx

B30-xxA

   

ESP100-xx-00

xx denotes different sizes available (e.g. B10-19A)

Non-clinical testing has demonstrated that the Biocor™ and Epic™ heart valve devices are MR Conditional. Patients can be scanned safely immediately after implantation under the following conditions:

  • Static magnetic field of 1.5 Tesla (T) or 3.0 T
  • Maximum spatial gradient field less than or equal to 3,000 Gauss/cm (30 T/m)
  • Normal Operating Mode: Maximum whole-body-averaged specific absorption rate (SAR) of:
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5 T
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0 T

3.0 T RF heating

In non-clinical testing with body coil excitation, the Biocor™ and Epic™ heart valve devices produced a differential temperature rise of less than or equal to 2.0˚C when exposed to a whole-body SAR of 2.8 W/kg for 15 minutes of scanning in a 3.0 T MR system (Siemens MAGNETOM Trio‡, SYNGO‡ MR A30 4VA30A software, Munich, Germany). Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than 2.0˚C.

1.5 T RF heating

In non-clinical testing with body coil excitation, the Biocor™ and Epic™ heart valve devices produced a differential temperature rise of less than or equal to 1.0˚C when exposed to a whole-body SAR of 1.4 W/kg for 15 minutes of scanning in a 1.5 T MR system (Siemens MAGNETOM Espree‡, SYNGO‡ MR B17 software, Munich, Germany). Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than 1.0˚C.

Caution: The RF heating behavior does not scale with static field strength. Devices which do not exhibit detectable heating at one field strength may exhibit high values of localized heating at another field strength.

MR Artifacts

MR image quality may be compromised if the area of interest is the same or relatively close to the position of the device, and it may be necessary to optimize the MR imaging parameters. The shape of the expected artifact follows the approximate contour of the device and extends radially up to 0.3 cm from the implant at 3.0 T and 0.2 cm at 1.5 T in gradient echo imaging tests performed in accordance with ASTM F2119-07.

TRIFECTA™ HEART VALVE

Models

 TF-xxA

xx denotes different sizes available (e.g. TF-19A)

Non-clinical testing has demonstrated that the Trifecta™ heart valve devices are MR Conditional. Patients can be scanned safely immediately after implantation under the following conditions:

  • Static magnetic field of 1.5 Tesla (T) or 3.0 T
  • Maximum spatial gradient field less than or equal to 3,000 Gauss/cm (30 T/m)
  • Normal Operating Mode: Maximum whole-body-averaged specific absorption rate (SAR) of:
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5 T
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0 T

3.0 T RF heating

In non-clinical testing with body coil excitation, the Trifecta™ heart valve device produced a differential temperature rise of less than or equal to 1.0˚C when exposed to a whole-body SAR of 3.4 W/kg for 15 minutes of scanning in a 3.0 T MR system (Siemens MAGNETOM Trio‡, SYNGO‡ MR A30 4VA30A software, Munich, Germany). Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than 1.0˚C.

1.5 T RF heating

In non-clinical testing with body coil excitation, the Trifecta™ heart valve device produced a differential temperature rise of less than or equal to 2.0˚C when exposed to a whole-body SAR of 1.4 W/kg for 15 minutes of scanning in a 1.5 T MR system (Siemens MAGNETOM Espree‡, SYNGO‡ MR B17 software, Munich, Germany). Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than or equal to 2.0˚C.

Caution: The RF heating behavior does not scale with static field strength. Devices which do not exhibit detectable heating at one field strength may exhibit high values of localized heating at another field strength.

MR Artifacts

MR image quality may be compromised if the area of interest is the same or relatively close to the position of the device, and it may be necessary to optimize the MR imaging parameters. The shape of the expected artifact follows the approximate contour of the device and extends radially up to 0.3 cm from the implant at 3.0 T and 0.2 cm at 1.5 T in gradient echo imaging tests performed in accordance with ASTM F2119-07.

TRIFECTA™ GT VALVE WITH GLIDE TECHNOLOGY

Models

TFGT-XXA

xx denotes different sizes available (e.g. TF-19A)

Magnetic Resonance (MR) Safety

Non-clinical testing has demonstrated the Trifecta™ Valve with Glide™ Technology (GT) is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

  • Static magnetic field of 1.5 tesla (1.5T) or 3.0 tesla (3.0T)
  • Maximum spatial field gradient of 3,000 gauss/cm (30 T/m)
  • Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2.0 W/kg (Normal Operating Mode)

RF Heating

Under the scan conditions defined above, the Trifecta™ Valve with Glide™ Technology (GT) is expected to produce a maximum temperature rise of less than 3ºC after 15 minutes of continuous scanning.

MR Artifacts

In non-clinical testing, the image artifact extended radially 0.6 cm from the prosthetic valve when imaged with a gradient echo pulse sequence and a 3.0T System.

CAUTION: The RF heating behavior does not scale with static field strength. Devices that do not exhibit detectable heating at one field strength may exhibit high values of localized heating at another field strength.

OTHER ANNULOPLASTY RINGS AND BANDS

Heart Valves and Repair Devices MRI Safety Information

RIGID SADDLE RING

Models

RSAR-xx

xx denotes different sizes available (e.g. RSAR-24)

Non-clinical testing has demonstrated that the Abbott rigid saddle rings are MR Conditional. Patients can be scanned safely immediately after implantation under the following conditions:

  • Static magnetic field of 1.5 Tesla (T) or 3.0 T
  • Maximum spatial gradient field less than or equal to 3,000 Gauss/cm (30 T/m)
  • Normal Operating Mode: Maximum whole-body specific absorption rate (SAR) of:
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5 T
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0 T

3.0 T RF heating

In non-clinical testing with body coil excitation, the Abbott rigid saddle rings produced a differential temperature rise of less than or equal to 1.0˚C when exposed to a whole-body SAR of 3.0 W/kg for 15 minutes of scanning in a 3.0 T MR system (Siemens MAGNETOM Trio‡, SYNGO‡ MR A30 4VA30A software, Munich, Germany). Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than 1.0˚C.

1.5 T RF heating

In non-clinical testing with body coil excitation, the Abbott rigid saddle rings produced a differential temperature rise of less than or equal to 1.0˚C when exposed to a whole-body SAR of 1.3 W/kg for 15 minutes of scanning in a 1.5 T MR system (Siemens MAGNETOM Espree‡, SYNGO‡ MR B17 software, Munich, Germany). Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than 2.0˚C.

Caution: The RF heating behavior does not scale with static field strength. Devices which do not exhibit detectable heating at one field strength may exhibit high values of localized heating at another field strength.

MR Artifacts

MR image quality may be compromised if the area of interest is the same or relatively close to the position of the device, and it may be necessary to optimize the MR imaging parameters. The shape of the expected artifact follows the approximate contour of the device and extended radially up to 0.9 cm from the implant at 3.0 T in gradient echo imaging and 0.7 cm from the implant at 1.5 T in gradient echo imaging tests performed in accordance with ASTM F2119-07.

The following products are labeled as MR Safe and not MR Conditional per ASTM F2503.

Models

Abbott Seguin Annuloplasty Ring

Attune™ Flexible Adjustable Annuloplasty Ring

Abbott Tailor™ Annuloplasty Ring

Abbott Tailor™ Annuloplasty Band

SARP-xx

AFR-xx

TARP-xx

TAB-xx

xx denotes different sizes available (e.g. SARP-24)

References

**Indications, contraindications, warnings, and precautions can be found in the product specific Important Safety Information (ISI) or Instructions for Use available at medical.abbott/manuals.
‡ Trademarks, including logos, and service marks marked with a ‡, indicate that the trademark is a registered or unregistered third party trademark and the property of its respective owner. See Terms and Conditions.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

rx-only-logoAMPLATZER™ DUCT OCCLUDER II

INTENDED FOR USE

The AMPLAZTER™ Duct Occluder II is a percutaneous transcatheter occlusion intended for the non-surgical closure of patent ductus arteriosus.

CONTRAINDICATIONS

The AMPLATZER™ Duct Occluder II is contraindicated for the following:

  • Patients weighing less than 6 kg
  • Patients less than 6 months of age
  • Patients with a window-type patent ductus arteriosus (ie, length less than 3mm) 
  • Patients with an active infection
  • Patients with thrombus at the intended site of implant
  • Patients with pulmonary hypertension with pulmonary vascular resistance of greater than 3 Wood units or Rp/Rs of greater than 0.4
  • Patients with patent ductus arteriosus greater than 12 mm in length by angiography
  • Patients with patent ductus arteriosus greater than 5.5 mm in diameter by angiography

WARNINGS

  • Patients at greater risk of complications can include:
  • Patients with descending aorta < 10 mm in diameter
  • Patients with cardiac anomalies requiring surgical or interventional correction
  • Patients with have had more than 2 lower respiratory infections within the last year
  • Do not release the occluder from the delivery wire if the occluder does not conform to its original configuration or If the occluder position is unstable. Recapture the occluder and redeploy. If still unsatisfactory, recapture the occluder and replace with a new occluder. 
  • The AMPLATZER™ Duct Occluder II should only be used by physicians trained in transcatheter defect closure techniques. 
  • Physicians must have an on-site surgeon available in the event the surgical removal of an occluder is required. 
  • Embolized occluders must be removed. Embolized occluders should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a catheter.
  • This device has not been studied in patients older than 18 years of age.

PRECAUTIONS

  • This device was sterilized with ethylene oxide and is for single use only. Do not use or re-sterilize this device. Attempts to re-sterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • Use before the expiration date noted on the product packaging. 
  • Patients should have an activated clotting time (ACT) of greater than 200 sec prior to device replacement. 
  • The AMPLATZER™ Duct Occluder II contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted. 
  • Use in specific populations
  • Pregnancy – Care should be taken to minimize the radiation exposure to the fetus and the mother.
  • Nursing mothers – There has been no quantitative assessment of the presence of leachables in breast milk. 
  • Store in a dry place. 
  • Do not use if the packaging sterile barrier is opened or damaged. 
  • Do not use contrast power injection with delivery catheter.
  • They physician should exercise clinical judgement in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.

MR CONDITIONAL

St. Jude Medical’s AMPLATZER™ Duct Occluder II device is manufactured of chemically etched nitinol wire, 80% platinum 20% iridium marker band and a 316L end screw.

Non-clinical testing has demonstrated that the AMPLATZER™ Duct Occluder II device is MR-Conditional. Patients can be scanned safely immediately after implantation under the following conditions:

  • Static magnetic field of 1.5 Tesla (1.5T) or 3.0 Tesla (3.0T).
  • Maximum spatial gradient field less than or equal to 30 T/m.
  • Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning.

In non-clinical testing with body coil excitation, the AMPLATZER™ Duct Occluder II device produced a differential temperature rise of less than or equal to 3.65°C when exposed to a maximum average whole body specific absorption rate (SAR) of 2.80 W/kg for 15 minutes of scanning in a 1.5 Tesla MR system (Siemens™ MAGNETOM Espree™, SYNGO™ MR B17 software, Erlangen, Germany). Scaling of the SAR and observed heating indicates that average whole body SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than or equal to approximately 1.0°C in Normal Operating Mode.

MR Image quality may be compromised if the area of interest is the same or relatively close to the position of the device. Therefore, it may be necessary to optimize the MR imaging parameters for the presence of this implant.

POTENTIAL ADVERSE EVENTS

Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to:

Air embolus; Allergic dye reaction; Allergic drug reaction; Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding; Cardiac perforation; Cardiac tamponade; Chest pain; Device embolization; Device erosion; Death; Fever; Headache/migraine; Hypertension; Hypotension; Myocardial infarction;Palpitations; Pericardial effusion; Pericarditis; Peripheral embolism; Pleural effusion; Pulmonary embolism; Reintervention for device removal; Stroke; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury; and Vessel perforation.

rx-only-logoAMPLATZER™ MUSCULAR VSD OCCLUDER

INDICATIONS AND USAGE

The AMPLATZER™ Muscular VSD Occluder is indicated for use in patients with a complex ventricular septal defect (VSD) of significant sizeto warrant closure (large volume left-to-right shunt, pulmonary hypertension, and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.

  • High-risk anatomical factors for transatrial or transarte­rial surgical closure include patients:
  • Requiring left ventriculotomy or an extensive right ventriculotomy.
  • With a failed previous VSD closure.
  • With multiple apical and/or anterior muscular VSDs (“Swiss cheese septum”).
  • With posterior apical VSDs covered by trabeculae.

CONTRAINDICATIONS

The AMPLATZER™ Muscular VSD Occluder is contraindicated for the following:

  • Patients with defects less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid)
  • Patients with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease
  • Patients with perimembranous (close to the aortic valve) VSD
  • Patients with post-infarction VSD
  • Patients who weigh less than 5.2 kg. (Patients smaller than 5.2 kg were studied in the clinical trial, but due to poor outcome, these patients have been contraindicated for device placement. Data from these patients has not been included in the overall analysis.)
  • Patients with sepsis (local/generalized)
  • Patients with active bacterial infections
  • Patients with contraindications to antiplatelet therapy or agents

WARNINGS

  • The AMPLATZER™ Muscular VSD Occluder and delivery system should only be used by those physicians trained in transcatheter defect closure techniques.
  • Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon.
  • Embolized devices must be removed. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.
  • Use on or before the last day of the expiration month noted on the product packaging.
  • The device is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
  • Do not use the device if the packaging sterile barrier is open or damaged.
  • Do not release the AMPLATZER™ Muscular VSD Occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable. Recapture the device and redeploy. If still unsatisfactory, recapture the device and replace with a new device.
  • Device closure in patients who have suffered a previous thromboembolic stroke should be discussed with the patient or family. In addition, consultation with a neurologist and hematologist is suggested to determine if the benefit of device closure outweighs the risk.

PRECAUTIONS

Handling

Store in a dry place.

Sizing

Accurate defect sizing is crucial and mandatory for AMPLATZER™ Muscular VSD Occluder device selection. The VSD should be assessed and sized at end diastole by transesophogeal echocardiography (TEE) or angiography to determine the appropriate device size. Device selection should be 2 mm larger than the defect size.

Procedural

  • This device contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
  • The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.
  • This device should only be used by physicians who have been trained in transcatheter techniques and who should determine which patients are suitable candidates for procedures using this device.
  • Aspirin (eg, 81 mg or 325 mg) or an alternative antiplate­let/ anticoagulant is recommended to be started at least 24 hours prior to the procedure. Cephalosporin therapy is optional.
  • Maintain a recommended minimum active clotting time (ACT) of 200 seconds prior to device insertion and throughout the procedure.
  • f TEE is used, the patient’s esophogeal anatomy must be adequate for placement and manipulation of the TEE probe.
  • Patients requiring multiple devices and/or concomitant catheterization procedures might require prolonged fluoroscopy times and multiple cineangiograms. The risks of radiation exposure (eg, increased cancer risk) should be discussed in detail with the patient or family and alternatives which do not involve radiation exposure should be reviewed.

Post-implant

  • Patients should be treated with antiplatelet/anticoagulation therapy (such as aspirin) for 6 months post-implant. The decision to continue antiplatelet/anticoagulation therapy beyond 6 months is at the discretion of the physician.
  • Endocarditis prophylaxis should be followed according to the American Heart Association recommendations.
  • Any patient who has a residual shunt should undergo an echocardiographic evaluation of the residual shunt every 6 months until complete closure of the defect has been confirmed.
  • Patients should be instructed to avoid strenuous activity for 1 month. Strenuous activities such as contact sports prior to 1 month after implant may cause the device to dislodge and embolize.

Use in Specific Populations

  • Pregnancy - Care should be taken to minimize the radiation exposure to the fetus and the mother.
  • Nursing mothers - There has been no quantitative assessment of the presence of leachables from the device/ procedure in breast milk, and the risk to nursing mothers is unknown.

MR Conditional1

Through non-clinical testing, AMPLATZER™ devices have been shown to be MR Conditional. A patient with an implanted AMPLATZER™ device can be scanned safely immediately after placement of the device under the following conditions:

  • Static magnetic field of 3 tesla or less
  • Spatial gradient magnetic field of 720 G/cm or less
  • Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

During testing, the device produced a clinically non-significant temperature rise at a maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning in a 3-tesla MR system using a transmit/ receive body coil.

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

POTENTIAL ADVERSE EVENTS

Potential adverse events may occur during or after a procedure using this device may include, but are not limited to:

Air embolus; Allergic drug reaction; Allergic dye reaction; Anemia; Anesthesia reactions; Apnea; Arrhythmia; Arterial pulse loss; Atelectasis; Bacterial endocarditis; Blood loss requiring transfusion; Brachial plexus injury; Cardiac arrest; Cardiomyopathy; Chest pain; Cyanosis; Death; Device embolization; Device fracture; Fever; Headache/migraine; Heart block; Hypotension; Myocardial infarction; Perforation of the vessel or myocardium; Peripheral embolism; Stridor; Stroke; Subaortic stenosis; Thrombus formation on device; Vascular access site injury; Venous thrombosis; Vomiting

1. MR Conditional as defined in ASTM F 2503-05.

rx-only-logoAMPLATZERTM PFO OCCLUDER

INDICATIONS AND USAGE

The AMPLATZER™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic

stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

CONTRAINDICATIONS

  • Patients with intra-cardiac mass, vegetation, tumor or thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.
  • Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size.
  • Patients with anatomy in which the AMPLATZER™ PFO device size required would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins.
  • Patients with other source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum.
  • Patients with active endocarditis or other untreated infections.

WARNINGS

  • Patients who are at increased risk for venous thromboembolic events should be managed with thromboembolic risk reduction regimen after the PFO Closure following standard of care.
  • Do not use this device if the sterile package is open or damaged.
  • Prepare for situations that require percutaneous or surgical removal of this device. This includes availability of a surgeon.
  • Embolized devices must be removed as they may disrupt critical cardiac functions. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter or sheath.
  • Patients who are allergic to nickel can have an allergic reaction to this device.
  • This device should be used only by physicians who are trained in standard transcatheter techniques.
  • Transient hemodynamic compromise may be encountered during device placement, which may require fluid replacement or other medications as determined by the physician.
  • Do not release the device from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device interferes with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). If the device interferes with an adjacent cardiac structure, recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or refer the patient for alternative treatment.
  • Ensure there is sufficient distance from the PFO to the aortic root or SVC (typically defined as 9 mm or greater as measured by echo). See Figure 6. and Figure 7.

PRECAUTIONS

  • The safety and effectiveness of the AMPLATZER™ PFO Occluder has not been established in patients (with):
  • Age less than 18 years or greater than 60 years because enrollment in the pivotal study (the RESPECT trial) was limited to patients 18 to 60 years old
  • A hypercoagulable state including those with a positive test for a anticardiolipin antibody (IgG or IgM), Lupus anticoagulant, beta-2 glycoprotein-1 antibodies, or persistently elevated fasting plasma homocysteine despite medical therapy
  • Unable to take antiplatelet therapy
  • Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥50% luminal stenosis\
  • Acute or recent (within 6 months) myocardial infarction or unstable angina
  • Left ventricular aneurysm or akinesis
  • Mitral valve stenosis or severe mitral regurgitation irrespective of etiology
  • Aortic valve stenosis (mean gradient greater than 40 mmHg) or severe aortic valve regurgitation
  • Mitral or aortic valve vegetation or prosthesis
  • Aortic arch plaques protruding greater than 4 mm into the aortic lumen
  • Left ventricular dilated cardiomyopathy with left ventricular ejection fraction (LVEF) less than 35%
  • Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
  • Uncontrolled hypertension or uncontrolled diabetes mellitus
  • Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event
  • Arterial dissection as cause of stroke
  • Index stroke of poor outcome (modified Rankin score greater than 3)
  • Pregnancy at the time of implant
  • Multi-organ failure
  • Use on or before the last day of the expiration month that is printed on the product packaging label.
  • This device was sterilized with ethylene oxide and is for single use only. Do not reuse or re-sterilize this device. Attempts to re-sterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • The AMPLATZER™ PFO Occluder device consists of a nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.
  • Store in a dry place.
  • Pregnancy – Minimize radiation exposure to the fetus and the mother.
  • Nursing mothers – There has been no quantitative assessment for the presence of leachables in breast milk.

ADVERSE EVENTS

Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus Allergic drug reaction; Allergic dye

reaction; Allergic metal reaction: Nitinol (nickel, titanium), platinum/iridium, stainless steel (chromium, iron, manganese, molybdenum, nickel); Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding ; Brachial plexus injury; Cardiac perforation; Cardiac tamponade; Cardiac thrombus; Chest pain; Device embolization; Device erosion; Deep vein thrombosis; Death; Endocarditis; Esophagus injury; Fever; Headache/migraine; Hypertension/hypotension; Myocardial infarction; Pacemaker placement secondary to PFO device closure; Palpitations; Pericardial effusion; Pericardial tamponade; Pericarditis; Peripheral embolism; Pleural effusion; Pulmonary embolism; Reintervention for residual shunt/device removal; Sepsis; Stroke; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury; Vessel perforation

rx-only-logoAMPLATZER™ SEPTAL OCCLUDER AND DELIVERY SYSTEM

INDICATIONS FOR USE

The AMPLATZER™ Septal Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects (ASD) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration.

Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement).

CONTRAINDICATIONS

The AMPLATZER™ Septal Occluder is contraindicated for the following:

  • Any patient known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery.
  • Any patient known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
  • Any patient known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months.
  • Any patient known to have a demonstrated intracardiac thrombi on echocardiography(especially left atrial or left atrial appendage thrombi).
  • Any patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
  • Any patient where the margins of the defect are less than 5 mm to the coronary sinus, inferior vena cava rim, AV valves, or right upper lobe pulmonary vein.

 WARNINGS

  • Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon.
  • Embolized devices must be removed as they may disrupt critical cardiac functions. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within the sheath.
  • Use on or before the expiration date noted on the product packaging.
  • This device is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
  • Do not use the device if the packaging sterile barrier is open or damaged.
  • Do not release the AMPLATZER™ Septal Occluder from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device inter­feres with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). Recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or refer the patient for alternative treatment.
  • Implantation of this device may not supplant the need for Coumadin™ in patients with ASD and paradoxical emboli.
  • The use of echocardiographic imaging (TTE, TEE, or ICE) is required.
  • Balloon sizing should be used to size the atrial septal defect using a stop-flow technique. Do not inflate the balloon beyond the cessation of the shunt (such as, stop-flow). DO NOT OVER INFLATE.
  • Patients with a retro-aortic rim of less than 5 mm in any echocardiographic plane, or patients in whom the device physically impinges on (i.e. indents or distorts) the aortic root, may be at increased risk of erosion.
  • Do not select a device size greater than 1.5 times the echocardiographic-derived ASD diameter prior to balloon sizing.

PRECAUTIONS

  • The use of this device has not been studied in patients with patent foramen ovale.
  • Use standard interventional cardiac catheteriza­tion techniques to place this device.
  • Placement of the AMPLATZER™ Septal Occluder may impact future cardiac interventions, for ex­ample transeptal puncture and mitral valve repair.
  • This device contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
  • MR Conditional to 3.0 Tesla
    Caution should be used if an MRI is performed with a magnetic field of >3.0 tesla.

    Through non-clinical testing, the AMPLATZER™ device has been known to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.0 tesla for a 20-minute exposure to a B1 of 118 μT. The AMPLATZER™device should not migrate in this MR environment. Non-clinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.

    In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla.

    MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

POTENTIAL ADVERSE EVENTS

Potential adverse events may occur during or after a procedure placing this device may include, but are not limited to:

Air embolus; Allergic dye reaction; Anesthesia reactions; Apnea; Arrhythmia; Cardiac tamponade; Death; Embolization; Fever Hypertension/hypotension; Infection including endocarditis; Need for surgery; Pericardial effusion; Perforation of vessel or myocardium; Pseudoaneurysm including blood loss requiring transfusion; Stroke; Tissue erosion; Thrombus formation on discs; Valvular regurgitation

rx-only-logoSJM REGENT™ MECHANICAL HEART VALVE

INDICATIONS

The SJM Regent™ Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. This device may also be used to replace a previously implanted aortic prosthetic heart valve.

CONTRAINDICATIONS

The SJM Regent™ Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

WARNINGS

  • For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.
  • Do not use if:
  • The valve has been dropped, damaged, or mishandled in any way.
  • The expiration date has elapsed.
  • The tamper-evident container seal or inner/outer tray seals are damaged, broken or missing.
  • Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.
  • Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM Regent™ Mechanical Heart Valve sizes, use the smaller size SJM Regent™ Mechanical Heart Valve.
  • Use only St. Jude Medical™ mechanical heart valve sizers.
  • The outer tray is not sterile, and should not be placed in the sterile field.
  • To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.
  • Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude Medical™ leaflet tester to gently test valve leaflet mobility.
  • Do not use cutting edge needles in the sewing cuff. If use of these needles is necessary, placement of sutures in the outer half of the sewing cuff is imperative.
  • Never apply force to the valve leaflets. Force may cause structural damage to the valve.
  • Use only the valve holder/rotator packaged with the SJM Regent™ Mechanical Heart Valve to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/rotator is intended for single use only and should be discarded after surgery.
  • The two retention sutures on the valve holder/rotator must be cut and removed before the SJM Regent™ Mechanical Heart Valve can be rotated.
  • Do not pass catheters or other instruments through St. Jude Medical™ mechanical heart valves. This could result in scratched or damaged valve components, or leaflet fracture or dislodgment.
  • Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.

PRECAUTIONS

  • Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.
  • Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the SJM Regent™ Mechanical Heart Valve.
  • Before placing sutures in the valve cuff, verify that the valve is mounted correctly on the valve holder/rotator.
  • To avoid structural damage, the valve must be rotated in the fully closed position.
  • To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve (Figures 15a and 15b).
  • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.

POTENTIAL ADVERSE EVENTS

Complications associated with replacement mechanical heart valves include, but are not limited to:

hemolysis; infections; thrombus; or thromboembolism;valve dehiscence; unacceptable hemodynamic performance; hemorrhagic complications secondary to anticoagulation therapy; prosthetic failure; and heart failure or death.

Any of these complications may require reoperation or explantation of the device.

rx-only-logoBIOCOR™/BIOCOR™ SUPRA VALVE

INDICATIONS FOR USE

The Biocor™ valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve.

The Biocor™ Supra valve is indicated as a replacement for a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

CONTRAINDICATIONS

None known.

WARNINGS

  • Valve size selection is based on the size of the recipient annulus, and for supra-annular aortic placement, the anatomy of the sinotubular space. Implantation of an inappropriately large bioprosthesis may result in stent deformation, valvular incompetence, and/or damage to the surrounding tissues. The use of an inappropriately small bioprosthesis may result in suboptimal hemodynamics. Use only the St. Jude Medical™ Sizer Set Model B1000 with Biocor and Biocor Supra valves.
  • Accelerated deterioration due to calcific degeneration of the Biocor and Biocor Supra valve may occur in:
  • children, adolescents, or young adults;
  • patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure); or
  • individuals requiring hemodialysis.
  • For single use only. Do not reuse or re-sterilize. Attempts to re-sterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
  • Passage of a catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.

Do not use if:

  • the valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration;
  • the expiration date has elapsed;
  • the tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging; or
  • the storage solution does not completely cover the valve.

PRECAUTIONS

  • The safety and effectiveness of the Biocor™ and Biocor™ Supra valves has not been established for the following specific populations:
  • patients who are pregnant
  • nursing mothers
  • patients with chronic renal failure
  • patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
  • patients with chronic endocarditis
  • patients requiring pulmonic or tricuspid valve replacement
  • children, adolescents, or young adults
  • Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, deformed, or damaged sizer set components.
  • Do not pass the flanged portion of the valve replica sizing tool through the annulus.
  • Do not place the non-sterile exterior of the valve container in the sterile field.
  • Do not expose the valve to solutions other than the formaldehyde valve storage solution in which it was shipped, the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline solution used to irrigate the valve.
  • Do not add antibiotics to either the formaldehyde valve storage solution or the rinse solution.
  • Do not apply antibiotics to the valve.
  • Do not allow the valve tissue to dry. Place the valve in sterile isotonic saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
  • Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5 °C to 25 °C range.
  • Do not implant the valve without thoroughly rinsing as directed.
  • Do not lacerate the valve tissue. If a valve is damaged, the valve must be explanted and replaced.
  • Do not attempt to repair a valve. Damaged valves must not be used.
  • Do not use cutting edge needles, unprotected forceps, or sharp instruments as they may cause structural damage to the valve.
  • Never handle the leaflet tissue.
  • Position the mitral valve in a manner to avoid commissure obstruction of the left ventricular outflow tract, and minimize any potential of commissure contact with the ventricular wall.
  • Position the aortic valve so that the stent posts do not obstruct the coronary ostia.
  • Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.

MRI SAFETY INFORMATION

Non-clinical testing has demonstrated that the Biocor™ and Epic™ heart valves are MR Conditional. Patients can be scanned safely immediately after implantation under the following conditions:

  • Static magnetic field of 1.5 tesla (1.5T) or 3.0 tesla (3.0T).
  • Maximum spatial gradient field less than or equal to 3,000 Gauss/cm (30T/m).
  • Normal Operating Mode: Maximum whole-body specific absorption rate (SAR) of:
  • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5T.
  • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0T.

1.5T RF Heating

In non-clinical testing with body coil excitation, the valves produced a differential temperature rise of less than or equal to 1.0ºC when exposed to a whole-body specific absorption rate (SAR) of 1.4 W/kg for 15 minutes of scanning in a 1.5-tesla MR system (Siemens™ MAGNETOM Espree™, SYNGO™ MR B17 software, Munich, Germany). Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than 1.0ºC.

3.0T RF Heating

In non-clinical testing with body coil excitation, the valves produced a differential temperature rise of less than or equal to 2.0ºC when exposed to a whole-body specific absorption rate (SAR) of 2.8 W/kg for 15 minutes of scanning in a 3.0-tesla MR system (Siemens MAGNETOM Trio™, SYNGO™ MR A30 4VA30A software, Munich, Germany). Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than 2.0ºC.

CAUTION: The RF heating behavior does not scale with static field strength. Devices that do not exhibit detectable heating at one field strength may exhibit high values of localized heating at another field strength.

MR Artifacts

MR image quality may be compromised if the area of interest is the same or relatively close to the position of the device, and it may be necessary to optimize the MR imaging parameters. The shape of the expected artifact follows the approximate contour of the device and extended radially up to 0.3 cm from the implant at 3.0T in gradient echo imaging and 0.2 cm from the implant at 1.5T in gradient echo imaging tests performed in accordance with ASTM F2119-07.

ADVERSE EVENTS

The clinical investigations of the Biocor™ valve support the safety and effectiveness of the Biocor™ Supra valve and include data from the two following independent institutions:

Sahlgrenska University Hospital, Gothenburg, Sweden

Between January 1983 and December 1999, 1492 patients requiring aortic and/or mitral valve replacement (AVR = 1263, MVR = 172, DVR = 57) were implanted at the Sahlgrenska University Hospital in Gothenburg, Sweden. The cumulative follow-up for the 1492 total patients in Sweden was 7718.1 patient-years with a mean follow-up of 5.2 years (s.d. = 4.3 years, range 0 – 16.9 years).

University of Padua Medical Center, Padua, Italy

Between May 1992 and December 2000, 442 patients requiring aortic and/or mitral valve replacement (AVR = 262, MVR = 129, DVR = 51) were implanted at the University of Padua Medical Center in Padua, Italy. The cumulative follow-up for the 442 total patients in Italy was 2080.9 patient-years with a mean follow-up of 4.7 years (s.d. = 2.8 years, range 0 – 11.4 years).

Potential Adverse Events

Adverse events potentially associated with the use of bioprosthetic heart valves (in alphabetical order) include:

angina; cardiac arrhythmias; endocarditis; heart failure; hemolysis; hemolytic anemia; hemorrhage; anticoagulant/antiplatelet-related; leak; transvalvular or paravalvular; myocardial infarction; nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other); prosthesis regurgitation; stroke; structural deterioration (calcification, leaflet tear, or other); thromboembolism; and valve thrombosis.

It is possible that these complications could lead to:

reoperation; explantation; permanent disability; and death.

rx-only-logoEPIC™/ EPIC™ SUPRA STENTED PORCINE TISSUE VALVES

INDICATION FOR USE

The Epic™ valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve.

The Epic™ Supra different valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

CONTRAINDICATIONS

None known.

WARNINGS

  • Valve size selection is based on the size of the recipient annulus, and for supra-annular aortic placement, the anatomy of the sinotubular space. Implantation of an inappropriately large bioprosthesis may result in stent deformation, valvular incompetence, and/or damage to the surrounding tissues. The use of an inappropriately small bioprosthesis may result in suboptimal hemodynamics. Use only the St. Jude Medical™ Bioprosthetic Heart Valve Sizer Set Model B1000 with the Epic and Epic Supra valves.
  • Accelerated deterioration due to calcific degeneration of the Epic and Epic Supra valve may occur in:
  • children, adolescents, or young adults;
  • patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure); or
  • individuals requiring hemodialysis.
  • For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
  • Passage of a catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.

Do not use if:

  • the valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration;
  • the expiration date has elapsed;
  • the tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging; or
  • the storage solution does not completely cover the valve.

PRECAUTIONS

The safety and effectiveness of the Epic™ and Epic™ Supra valves has not been established for the following specific populations:

  • patients who are pregnant
  • nursing mothers
  • patients with chronic renal failure
  • patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
  • patients with chronic endocarditis
  • patients requiring pulmonic or tricuspid valve replacement
  • children, adolescents, or young adults
  • Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, deformed, or damaged sizer set components.
  • Do not pass the flanged portion of the valve replica sizing tool through the annulus.
  • Do not place the non-sterile exterior of the valve container in the sterile field.
  • Do not expose the valve to solutions other than the formaldehyde valve storage solution in which it was shipped, the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline solution used to irrigate the valve.
  • Do not add antibiotics to either the formaldehyde valve storage solution or the rinse solution.
  • Do not apply antibiotics to the valve.
  • Do not allow the valve tissue to dry. Place the valve in sterile isotonic saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
  • Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5 °C to 25 °C range.
  • Do not implant the valve without thoroughly rinsing as directed.
  • Do not lacerate the valve tissue. If a valve is damaged, the valve must be explanted and replaced.
  • Do not attempt to repair a valve. Damaged valves must not be used.
  • Do not use cutting edge needles, unprotected forceps, or sharp instruments as they may cause structural damage to valve.
  • Never handle the leaflet tissue.
  • Position the mitral valve in a manner to avoid commissure obstruction of the left ventricular outflow tract, and minimize any potential of commissure contact with the ventricular wall.
  • Position the aortic valve so that the stent posts do not obstruct the coronary ostia.
  • Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.

ADVERSE EVENTS

The clinical investigation of the Epic valve supports the safety and effectiveness of the Epic valve and the Epic Supra valve. Between January 2003 and March 2006, seven-hundred and sixty-two (762) subjects were implanted with 791 Epic Valve(s) at 19 investigational sites in the United States (U.S.), and three sites in Canada. Five-hundred and fifty-seven (557) subjects received isolated aortic replacement, 176 received isolated mitral replacement, and 29 received replacement of both the aortic and mitral valves. The cumulative follow-up for all subjects was 773.51 patient-years with a mean follow-up of 1.02 patient-years (s.d. = 0.71 patient-years, range 0 – 3.10 patient-years).

Potential Adverse Events

Adverse events potentially associated with the use of bioprosthesis heart valves (in alphabetical order) include:

  • angina
  • cardiac arrhythmias
  • endocarditis
  • heart failure
  • hemolysis
  • hemolytic anemia
  • hemorrhage, anticoagulant/antiplatelet-related
  • leak, transvalvular or paravalvular
  • myocardial infarction
  • nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
  • prosthesis regurgitation
  • stroke
  • structural deterioration (calcification, leaflet tear, or other)
  • thromboembolism
  • valve thrombosis

It is possible that these complications could lead to:

  • reoperation
  • explantation
  • permanent disability
  • death

rx-only-logoTRIFECTA™ VALVE WITH GLIDE™ TECHNOLOGY (GT)

INDICATION FOR USE

The Trifecta™ Valve with Glide™ Technology is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.

CONTRAINDICATIONS

None known.

WARNINGS

  • For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
  • Do not oversize. Valve size selection is based on the size of the recipient annulus and the anatomy of the sinotubular junction. If the native annulus measurement falls between the two valve sizes, use the smaller size valve. Use only the Model TF2000 Trifecta™ Sizers for sizing the valve. Implantation of an oversized valve may result in stent deformation, valvular incompetence, valve damage, diminished tissue durability, and/or damage to the surrounding tissues.
  • Passage of a diagnostic catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
  • Accelerated deterioration due to calcific degeneration of the valve may occur in:
    • Children, adolescents, or young adults
    • Patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure)
    • Individuals requiring hemodialysis

Do not use if:

  • The valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration.
  • The expiration date has elapsed.
  • The tamper-evident jar seal is damaged, broken, or missing, or if fluid is leaking from the packaging.
  • The storage solution does not completely cover the valve.
  • Use only the Trifecta™ Model TF2000 sizers1 for sizing the valve.
  • The titanium valve stent is not designed as a flexible stent. Do not bend the titanium valve stent. Deformation of the stent may impair valve function.

PRECAUTIONS

  • Safety and effectiveness of the valve has not been established for the following specific populations:
    • Patients who are pregnant
    • Nursing mothers
    • Patients with chronic renal failure
    • Patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
    • Patients with chronic endocarditis
    • Patients requiring pulmonic or tricuspid valve replacement
    • Children, adolescents, or young adults
  • Sizer sets are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, crazed, or deformed sizer set components.
  • Do not place the non-sterile exterior of the valve jar in the sterile field.
  • Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5°C–25°C (41°F–77°F) range.
  • Do not expose the valve to solutions other than the formaldehyde solution in which it was shipped, the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline used to irrigate the valve.
  • Do not add antibiotics to either the valve storage solution or the rinse solution.
  • Do not apply antibiotics to the valve.
  • Do not allow the valve tissue to dry. Place the valve in isotonic sterile saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
  • Do not implant the valve without thoroughly rinsing as directed.
  • Position the valve so that the stent posts do not obstruct the coronary ostia.
  • Never handle the leaflet tissue.
  • Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.
  • Use caution when placing sutures through the sewing cuff to avoid lacerating the valve tissue. If a valve is damaged, the valve must be replaced.
  • Do not use cutting edge needles, unprotected forceps, or sharp instruments, as they may cause structural damage to the valve.
  • Do not attempt to repair a valve. Damaged valves must not be used.
  • Do not pass the replica end of the TF2000 sizer through the annulus when sizing the valve.
  • Use caution when tying knots to avoid bending the stent posts.

ADVERSE EVENTS

The Trifecta™ Valve with Glide™ Technology is based upon the Trifecta™ Valve design. Therefore, a previous clinical investigation of the Trifecta Valve supports the safety of the Trifecta Valve with Glide Technology. Between June 2007 and November 2009, one thousand and twenty-two (1022) subjects were implanted with the Trifecta valve in the aortic position at 31 investigational sites in the United States (18), Canada (7), and Europe (6). Data are presented on the one thousand and fourteen (1014) subjects who met eligibility criteria. The cumulative follow-up for all subjects was 924.18 patient-years with a mean follow-up of 0.91 years (SD = 0.49 years, range 0 - 2.38 years).

Adverse events potentially associated with the use of bioprosthetic heart valves include:

  • angina
  • cardiac arrhythmias
  • endocarditis
  • heart failure
  • hemolysis
  • hemolytic anemia
  • hemorrhage, anticoagulant/antiplatelet-related
  • leak, transvalvular or paravalvular
  • myocardial infarction
  • nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
  • prosthesis regurgitation
  • stroke
  • structural deterioration (calcification, leaflet tear, or other)
  • thromboembolism
  • valve thrombosis

It is possible that these complications could lead to:

  • reoperation
  • explantation
  • permanent disability
  • death

See the Clinical Study section of these instructions for adverse event data collected in the Trifecta™ Valve clinical investigation.

1. TF2000 sizers are included in sizer set models TF2000 and TF2000-2.

rx-only-logoTRIFECTA™ VALVE

INDICATION FOR USE

The Trifecta Valve is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.

CONTRAINDICATIONS

None known.

WARNINGS

  • For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
  • Valve size selection is based on the size of the recipient annulus and the anatomy of the sinotubular junction. Implantation of an inappropriately large bioprosthesis may result in stent deformation, valvular incompetence, and/or damage to the surrounding tissues. Do not oversize the valve. If the native annulus measurement falls between two Trifecta Valve sizes, use the smaller size Trifecta Valve. Use only the Model TF2000 Trifecta™ Valve Sizer Set for sizing a Trifecta Valve.
  • Passage of a catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
  • Accelerated deterioration due to calcific degeneration of the Trifecta Valve may occur in:
    • Children, adolescents, or young adults
    • Patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure)
    • Individuals requiring hemodialysis
  • The titanium valve stent is not designed as a flexible stent. Do not bend the titanium valve stent. Deformation of the stent may impair valve function.

Do not use if:

  • The valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration.
  • The expiration date has elapsed.
  • The tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging.
  • The storage solution does not completely cover the valve.

PRECAUTIONS

  • The safety and effectiveness of the Trifecta Valve have not been established for the following specific populations:
    • Patients who are pregnant
    • Nursing mothers
    • Patients with chronic renal failure
    • Patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
    • Patients with chronic endocarditis
    • Patients requiring pulmonic or tricuspid valve replacement
    • Children, adolescents, or young adults
  • Sizers and holder handles are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, crazed, or deformed sizer set components.
  • Do not pass the replica end of the TF2000 sizer through the annulus when sizing the valve.
  • Position the valve so that the stent posts do not obstruct the coronary ostia.
  • Do not place the non-sterile exterior of the valve container in the sterile field.
  • Do not expose the valve to solutions other than the formaldehyde solution in which it was shipped, the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline used to irrigate the valve.
  • Do not apply antibiotics to the valve.
  • Do not allow the valve tissue to dry. Place the valve in isotonic sterile saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
  • Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5°C to 25°C (41°F to 77°F) range.
  • Do not implant the valve without thoroughly rinsing as directed.
  • Use caution when placing sutures through the sewing cuff to avoid lacerating the valve tissue. If a valve is damaged, the valve must be replaced.
  • Do not attempt to repair a valve. Damaged valves must not be used.
  • Do not use cutting edge needles, unprotected forceps, or sharp instruments, as they may cause structural damage to the valve.
  • Use caution when tying knots to avoid bending the stent posts.
  • Never handle the leaflet tissue.
  • Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.

ADVERSE EVENTS

The clinical investigation of the Trifecta Valve supports the safety of the Trifecta Valve. Between June 2007 and November 2009, one thousand and twenty‑two (1022) subjects were implanted with the Trifecta Valve in the aortic position at 31 investigational sites in the United States (18), Canada (7), and Europe (6). Data are presented on the one thousand and fourteen (1014) subjects who met eligibility criteria. The cumulative follow-up for all subjects was 924.18 patient‑years with a mean follow‑up of 0.91 years (SD = 0.49 years, range 0 – 2.38 years).

Adverse events potentially associated with the use of bioprosthetic heart valves (in alphabetical order) include:

Adverse events potentially associated with the use of bioprosthetic heart valves include:

  • Angina
  • Cardiac arrhythmias
  • Endocarditis
  • Heart failure
  • Hemolysis
  • Hemolytic anemia
  • Hemorrhage
  • Leak, transvalvular or perivalvular
  • Myocardial infarction
  • Nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
  • Prosthesis regurgitation
  • Stroke
  • Structural deterioration (calcification, leaflet tear, perforation, or other)
  • Thromboembolism
  • Valve thrombosis

It is possible that these complications could lead to:

  • Reoperation
  • Explantation
  • Permanent disability;
  • Death

rx-only-logoATTUNE™ FLEXIBLE ADJUSTABLE ANNUPLASTY RING

INDICATIONS

The Attune™ Flexible Adjustable Annuloplasty Ring is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital valvular disease. It is the responsibility of the surgeon to determine that the valve is repairable and does not require replacement. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using an Attune™ Ring.

CONTRAINDICATIONS

Use of the Attune™ Flexible Adjustable Annuloplasty Ring is contraindicated in cases where severe organic lesions with retracted chordae tendineae require valvular replacement, and where there are congenital malformations which lack valvular tissue. Additionally, use of the Attune™ Ring is contraindicated whenever the physician determines that the remaining functional valve tissue and valve support structures are not adequate to provide the required hemodynamic performance or structural strength.

Use of the Attune™ Ring is contraindicated for active bacterial endocarditis.

 PRECAUTIONS

  • Do not use an Attune™ Flexible Adjustable Annuloplasty Ring if the “USE BY” date on the packaging has passed.
  • Examine the device packaging carefully, and ensure the tray is unopened and unbroken. If you note any damage, do not use the device, and contact St. Jude Medical™ Customer Service.
  • Sizers are supplied non-sterile and must be cleaned and sterilized prior to each use.
  • Do not used cracked, crazed, corroded, deformed, damaged, or degraded sizer set components.
  • Prior to using the sizers in the SJM Tailor™ & Attune™ Ring Robotic Sizer Set models TAR-510R or TAR-505R, secure a suture to the sizer using the safety suture hole. The suture should be long enough to remain outside the patient at all times the sizer is inside the patient. In the event that the sizer is dropped inside the patient, the safety suture can be used to retrieve the sizer.
  • Remove the Attune™ Ring from the support prior to implantation.
  • Remove the identification tag and suture prior to implantation. Avoid cutting or tearing the Attune™ Ring when removing the identification tag and suture.
  • Do not cut the Attune™ Ring.
  • To avoid damage to the Attune™ Ring, do not use cutting edge needles, and exercise care when holding or manipulating the Attune™ Ring with forceps.
  • Implantation of the Attune™ Ring has not been evaluated with the use of nitinol clips.
  • Do not place suture(s) through the posterior portion of the Attune™ Ring prior to finalizing and securing the adjustment, as this may result in disabling the adjustment suture.
  • Do not place sutures in the circumflex coronary artery or in the right coronary artery.
  • Do not place sutures in the atrial tissue, as this may result in impairment of the cardiac conduction system.
  • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
  • Prophylactic antibiotic treatment should be considered for all patients undergoing dental procedures.

POTENTIAL ADVERSE EVENTS

As with prosthetic heart valves, serious complications may be associated with the use of this device, sometimes leading to death.

Complications necessitating reoperation may occur at varying intervals and include:

thrombus; hemolysis; left ventricular outflow tract obstruction; systolic anterior motion; damage to coronary arteries; stenosis; uncorrected or recurrent regurgitation; partial or complete dislodgment of the Attune™ Ring from its site of attachment;

thromboembolism; A-V block; endocarditis; low cardiac output; and bleeding disorders relating to the use of anticoagulant therapy.

rx-only-logoATTUNE™ FLEXIBLE ADJUSTABLE ANNUPLASTY RING

INDICATIONS

The Attune™ Flexible Adjustable Annuloplasty Ring is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital valvular disease. It is the responsibility of the surgeon to determine that the valve is repairable and does not require replacement. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using an Attune™ Ring.

CONTRAINDICATIONS

Use of the Attune™ Flexible Adjustable Annuloplasty Ring is contraindicated in cases where severe organic lesions with retracted chordae tendineae require valvular replacement, and where there are congenital malformations which lack valvular tissue. Additionally, use of the Attune™ Ring is contraindicated whenever the physician determines that the remaining functional valve tissue and valve support structures are not adequate to provide the required hemodynamic performance or structural strength.

Use of the Attune™ Ring is contraindicated for active bacterial endocarditis.

 PRECAUTIONS

  • Do not use an Attune™ Flexible Adjustable Annuloplasty Ring if the “USE BY” date on the packaging has passed.
  • Examine the device packaging carefully, and ensure the tray is unopened and unbroken. If you note any damage, do not use the device, and contact St. Jude Medical™ Customer Service.
  • Sizers are supplied non-sterile and must be cleaned and sterilized prior to each use.
  • Do not used cracked, crazed, corroded, deformed, damaged, or degraded sizer set components.
  • Prior to using the sizers in the SJM Tailor™ & Attune™ Ring Robotic Sizer Set models TAR-510R or TAR-505R, secure a suture to the sizer using the safety suture hole. The suture should be long enough to remain outside the patient at all times the sizer is inside the patient. In the event that the sizer is dropped inside the patient, the safety suture can be used to retrieve the sizer.
  • Remove the Attune™ Ring from the support prior to implantation.
  • Remove the identification tag and suture prior to implantation. Avoid cutting or tearing the Attune™ Ring when removing the identification tag and suture.
  • Do not cut the Attune™ Ring.
  • To avoid damage to the Attune™ Ring, do not use cutting edge needles, and exercise care when holding or manipulating the Attune™ Ring with forceps.
  • Implantation of the Attune™ Ring has not been evaluated with the use of nitinol clips.
  • Do not place suture(s) through the posterior portion of the Attune™ Ring prior to finalizing and securing the adjustment, as this may result in disabling the adjustment suture.
  • Do not place sutures in the circumflex coronary artery or in the right coronary artery.
  • Do not place sutures in the atrial tissue, as this may result in impairment of the cardiac conduction system.
  • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
  • Prophylactic antibiotic treatment should be considered for all patients undergoing dental procedures.

POTENTIAL ADVERSE EVENTS

As with prosthetic heart valves, serious complications may be associated with the use of this device, sometimes leading to death.

Complications necessitating reoperation may occur at varying intervals and include:

thrombus; hemolysis; left ventricular outflow tract obstruction; systolic anterior motion; damage to coronary arteries; stenosis; uncorrected or recurrent regurgitation; partial or complete dislodgment of the Attune™ Ring from its site of attachment;

thromboembolism; A-V block; endocarditis; low cardiac output; and bleeding disorders relating to the use of anticoagulant therapy.

rx-only-logoSJM™ SÉGUIN ANNULOPLASTY RING / SJM™ SÉGUIN ANNULOPLASTY RING SIZER SET MODEL SAR-501

INDICATIONS

The SJM™ Séguin Annuloplasty Ring is indicated for use in the repair of mitral valves that are diseased or damaged due to acquired or congenital processes. It is the responsibility of the surgeon to determine that the valve is repairable and does not require replacement. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using the SJM™ Séguin Annuloplasty Ring.

The SJM™ Séguin Annuloplasty Ring Sizer Set Model SAR-501 is indicated for use with the SJM™ Séguin Annuloplasty Ring.

CONTRAINDICATIONS

Use of the SJM™ Séguin Annuloplasty Ring is contraindicated in cases where severe organic lesions with retracted chordae tendineae require valvular replacement and where there are congenital malformations which lack valvular tissue. Additionally, use of the ring is contraindicated whenever the physician determines that the remaining functional valve tissue and valve support structures are not adequate to provide the required hemodynamic performance or structural strength.

Use of the SJM™ Séguin Annuloplasty Ring is contraindicated for active bacterial endocarditis.

Use of the SJM™ Séguin Annuloplasty Ring Sizer Set Model SAR-501 with products other than the SJM™ Séguin Annuloplasty Ring is contraindicated.

When sterilizing the SAR-501 sizer set, any sterilization method other than steam is contraindicated.

PRECAUTIONS

  • SJM™ Séguin Annuloplasty Ring
  • Do not use the ring if the “USE BY” date on the packaging has passed.
  • Examine the device packaging carefully, and ensure the pouch is unopened and unbroken. If you note any damage, do not use the device, and contact St. Jude Medical™ customer service.
  • Remove the identification tag and suture prior to implantation. Avoid cutting or tearing the ring during removal of the identification tag and suture.
  • Do not place sutures in the circumflex coronary artery or in the right coronary artery.
  • Do not place sutures in the atrial tissue, as this may result in impairment of the cardiac conduction system.
  • Do not attempt to deform or otherwise alter the configuration of the prosthetic ring to conform to a specific annular anatomy, as this could damage the ring. If the ring is not suitably sized for the annulus, a larger or smaller ring should be chosen.
  • To avoid damage to the fabric covering the ring, do not use cutting edge needles, and avoid manipulation with forceps during implantation.
  • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
  • Prophylactic antibiotic treatment should be considered for all patients undergoing dental or other potentially bacteremic procedures.

 

SJM™ Séguin Annuloplasty Ring Sizer Set Model SAR-501

  • All sizer set components are supplied non-sterile, and must be cleaned and steam sterilized prior to each use.
  • The sterilization temperature must not exceed 138°C (280°F).
  • The autoclavable tray and cover do not provide a sterile barrier.
  • Do not use cracked, deformed, or damaged sizer set components.
  • Do not bend handles beyond a 90° angle.
  • Do not expose sizer set components to cleaning or rinse agents that are not compatible with polysulfone or polyphenylsulfone.

POTENTIAL ADVERSE EVENTS

As with prosthetic heart valves, serious complications may be associated with the use of this device, sometimes leading to death.

Complications necessitating re-operation may occur at varying intervals and include:

thrombus; hemolysis; ring fracture; left ventricular outflow tract obstruction; systolic anterior motion; damage to coronary arteries; stenosis; uncorrected or recurrent regurgitation; partial or complete dislodgment of the ring from its site of attachment; thromboembolism; A-V block; endocarditis; low cardiac output; and bleeding disorders relating to the use of anticoagulant therapy.

rx-only-logoSJM TAILOR™ ANNULOPLASTY RING OR SJM TAILOR™ ANNULOPLASTY BAND

INDICATIONS

The ring/band is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital valvular disease. It is the responsibility of the surgeon to determine that the valve is repairable. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using the ring/band.

CONTRAINDICATIONS

Use of the ring/band is contraindicated in cases where severe organic lesions with retracted chordae tendineae require valvular replacement, and where there are congenital malformations which lack valvular tissue. Additionally, use of the ring/band is contraindicated whenever the physician determines that the remaining functional valve tissue and valve support structures are not adequate to provide the required hemodynamic performance or structural strength.

Use of the ring/band is contraindicated for active bacterial endocarditis.

PRECAUTIONS

  • Sizers and accessories are supplied non-sterile, and must be cleaned and sterilized prior to each use.
  • Do not use cracked, crazed, deformed, or damaged sizer set components.
  • Do not bend sizers beyond a 90° angle.
  • Prior to using the sizers in the SJM Tailor™ & Attune™ ring robotic sizer set model TAR-510R, secure a suture to the sizer using the safety suture hole (see Figure 2). The suture should be long enough to remain outside the patient at all times the sizer is inside the patient. In the event that the sizer is dropped inside the patient, the safety suture can be used to retrieve the sizer.
  • Do not use a ring/band if the “USE BY” date on the packaging has passed.
  • The contents of the tray in which the ring/band is supplied have been sterilized. Ensure the tray is unopened and unbroken. If you note any damage, do not use the device, and contact St. Jude Medical™ Customer Service.
  • Remove the identification tag and suture prior to implantation. Avoid cutting or tearing the ring/ band during removal of the identification tag and suture.
  • Do not place sutures in the circumflex coronary artery or in the right coronary artery.
  • Do not place sutures in the atrial tissue, as this may result in impairment of the cardiac conduction system.
  • After selecting the appropriate size ring, should the surgeon elect to convert the ring to a C-band, the ring must be cut within the designated cut area. The cut area is identified by the two notched windows on the ring holder just inside the trigone indicator tabs. Once the ring has been cut, remove the cut segment prior to implantation of the ring.
  • After the ring has been cut and the cut segment removed, care should be taken to remove any loose suture within the cut area prior to implantation of the ring.
  • To avoid damage to the fabric covering the ring/ band, cutting edge needles should not be used, and manipulation with forceps should be avoided during implantation.
  • If an implant suture inadvertently pierces a ring/ band retaining loop, the holder may not release from the ring/band. To facilitate release, cut the retaining loop suture close to the implant suture.
  • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
  • Prophylactic antibiotic treatment should be considered for all patients undergoing dental or other potentially bacteremic procedures.

POTENTIAL ADVERSE EVENTS

As with prosthetic heart valves, serious complications may be associated with the use of this device, sometimes leading to death.

Complications necessitating reoperation may occur at varying intervals and include:

thrombus; hemolysis; left ventricular outflow tract obstruction; systolic anterior motion; damage to coronary arteries; stenosis; uncorrected or recurrent regurgitation; partial or complete dislodgment of the ring/band from its site of attachment; thromboembolism; A-V block; endocarditis; low cardiac output; and bleeding disorders relating to the use of anticoagulant therapy.

AP2946783-WBU Rev. A

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