CARDIOVASCULAR
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MR CONDITIONAL INFORMATION FOR RADIOLOGISTS

We offer MRI Ready (MR Conditional) products for:

  • Cardiac pacing, defibrillation and monitoring
  • Structural heart and vascular disease treatment and therapy

Below please find scan details for our MRI Ready products, grouped by practice area.

MRI Ready devices are commercially available for use in select international markets.

 

CARDIAC RHYTHM MANAGEMENT AND ELECTROPHYSIOLOGY RESOURCES

MRI READY SCAN PARAMETERS PRODUCT SEARCH

Our look-up tool provides scan parameter information about our MRI Ready pacemakers and leads.

Use the tool:

PACEMAKERS

Some of our MRI Ready pacemakers have high-power scan capability, so you can use the best available diagnostic tools without worry. Those include cardiac scan sequences up to 4 W/kg and spinal and other thoracic scans.

 

 Clinician Checklist

DE |ES |IT

  MRI ready Clinician Checklist

 Pacemaker MRI Summary Report PDF

 Pacemaker MRI Settings Alert

Our MRI Ready Products Eliminate Steps, Streamlining Workflow

How much more could you get done if you did not have to worry about reprogramming pacing devices before and after an MRI scan? With the St. Jude Medical MRI Activator™ handheld device, you can turn off and on pre-established MRI settings on all of our MRI Ready pacemakers. Less time and effort spent on pre- and post-scan device reprogramming. No more patient inconvenience; just a streamlined workflow.

The traditional workflow process for MRI patients
A streamlined workflow process for MRI patients
SJM Confirm™ Implantable Cardiac Monitors

The SJM Confirm™ implantable cardiac monitor (ICM) DM2102 is conditionally safe for use in the MRI environment when used in accordance to the instructions in the user manual. Patients with newly implanted or previously implanted devices can undergo MR scanning when following specific scanning conditions.

These conditions include:

  • Closed bore-cylindrical magnet.
  • Static magnetic field strength of 1.5 Tesla (T) only.
  • Maximum gradient slew rate 200 T/m/s per axis.
  • Whole-body specific absorption rate (SAR) less than or equal to 2.0 W/kg.
  • The uninterrupted duration of active scanning (when radio frequency and gradients are on) over the chest during MRI must not exceed 60 minutes.
  • Confirmation of absence of other contraindicated implantable devices and/or leads, including abandoned leads, lead extenders and lead adaptors.
  • In non-clinical testing, the Confirm ICM produced a temperature rise of less than 3°C at a maximum MR system-reported whole-body-averaged SAR of 3.9 W/kg as displayed on the MR scanner console for 60 minutes of MR scanning in a 1.5 T closed-bore MR scanner (manufacturer Philips, model Intera 1.5, software version: 9.5.2).

For additional information, including contraindications and potential adverse events please refer to the SJM Confirm ICM User’s Manual. It is important to read the information in the MRI Procedure section of the user manual before conducting an MRI scan on a patient with an implanted SJM Confirm implantable cardiac monitor.

IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDs)

 MRI Scan Patient Checklist

 

Fortify Assura™ ICD

 

The Fortify Assura™ ICD allows full-body, 1.5T MRI scans that meet certain scan conditions, when combined with specific lead and lead lengths that are MR Conditional.*

  • Meets industry-standard MRI testing requirements
  • Capable of full body 1.5T MRI imaging scans

 

Ellipse™ ICD

 

The Ellipse™ ICD is built for the real world. We worked with physicians to determine what they wanted most from an ICD: patient safety and comfort. We turned those ideas into the Ellipse ICD. 

  • Small, physician-designed shape
  • Up to 36 J delivered energy
  • Tailored Therapy™ features
  • Wireless remote monitoring with Merlin@home™ Transmitter

Now MRI ready

The Ellipse ICD System allows full-body, 1.5T MRI scans* that meet certain scan conditions.

  • Meets industry-standard MRI testing requirements
  • Capable of full body 1.5T MRI imaging scans

HEART FAILURE MANAGEMENT RESOURCES

CardioMEMS™ HF System

Non-clinical testing demonstrated that the CardioMEMS™ PA sensor is MR Conditional. A patient with this device 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 magnetic field of 720 Gauss/cm (7200 mT/m) or less.

In non-clinical testing, the CardioMEMS™ PA sensor produced the temperatures in the table below during MRI performed for 15 minutes of scanning (per pulse sequence) in the 1.5 T/64 MHz1 and 3 T/128 MHz2 MR systems. These temperature changes will not pose a hazard to the patient under the conditions indicated.

Table 2. MRI Related Heating

 

1.5 Tesla

3 Tesla

MR system reported whole body averaged SAR

2.9 W/kg

2.9 W/kg

Calorimetry measured values, whole body averaged SAR

2.1 W/kg

2.7 W/kg

Highest temperature change

1.9°C

2.3°C

MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the sensor. Selecting optimal MR imaging parameters to compensate for the presence of the sensor may be necessary. The maximum artifact size (as seen on the gradient echo pulse sequence) extends approximately 5 mm relative to the size and shape of the sensor.

Table 3. Artifact Information

Pulse sequence

T1-SE

T1-SE

GRE

GRE

Signal void size

305 mm2

34 mm2

645 mm2

101 mm2

Plane orientation

Parallel

Perpendicular

Parallel

Perpendicular

MULTIPOINT™ PACING PRODUCTS
Quadra Assura MP™ CRT-D and Quartet™ Quadripolar LV Lead

The Quadra Assura MP™ CRT-D and the Quartet™ Quadripolar LV lead allow full-body, 1.5T MRI scans* that meet certain scan conditions.

  • Meet industry-standard MRI testing requirements
  • Capable of full body 1.5T MRI imaging scans

STRUCTURAL HEART RESOURCES

 
AMPLATZER™ IMPLANTABLE DEVICES

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™ Muscular VSD Occluder Devices
  • Static magnetic field of 3 Tesla (T) or less.
  • Spatial gradient field of 720 Gauss/cm.
  • Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning.
AMPLATZER™ Septal Occluder, AMPLATZER™ Multi-Fenestrated Septal Occluder – “Cribriform,” AMPLATZER™ Duct Occluder and AMPLATZER™ Vascular Plug Devices
  • Caution is advised for magnetic field strength greater than 3 T
  • Maximum MR system reported, whole-body-averaged SAR of 3.83 W/kg at 1.5 T and 5.57 W/kg at 5 T for 20 minutes of scanning
MECHANICAL HEART VALVES
SJM 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 safely scanned, 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 SJM Regent™ mechanical heart valves produced a differential temperature rise of less than or equal to 1.0ºC 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, SYNGOMR 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 SJM 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.

SJM™ 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

 

xxVVGJ-515

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 safely scanned, 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
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 2.0ºC 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 1.0ºC 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 2.0ºC 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.

ANNULOPLASTY RINGS
SJM Rigid Saddle Ring

Models

RSAR-xx

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

Non-clinical testing has demonstrated that the SJM 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 SJM rigid saddle rings produced a differential temperature rise of less than or equal to 1.0ºC 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 SJM rigid saddle rings produced a differential temperature rise of less than or equal to 1.0ºC 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

     

SJM Seguin Annuloplasty Ring

Attune™ Flexible Adjustable Annuloplasty Ring

SJM Tailor™ Annuloplasty Ring

SJM Tailor™ Annuloplasty Band

SARP-xx

AFR-xx

TARP-xx

TAB-xx

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

REFERENCES

*See MRI Ready Systems Manual for device and lead combinations and associated MRI scan parameters.

**Indications, contraindications, warnings and precautions can be found in the Instructions for Use available by request or online at medical.abbott/manuals.

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