1
CARDIOVASCULAR
hamburger

Designed for optimal ASD Occlusion

Amplatzer™ Septal Occluders are the standard of care for minimally invasive ASD closure. These double-disc occluders are comprised of Nitinol mesh with polyester fabric. They are designed to securely appose the septal wall on each side of the defect and create a platform for tissue in-growth after implantation.

Abbott Offers Two ASD Occluders

Variety Matters

ASDs come in a variety of shapes and sizes. There can often be multiple, or fenestrated, ASDs. Abbott offers two percutaneous, transcatheter occluders for different types of ASDs.

Amplatzer Septal Occluder

The Amplatzer Septal Occluder has a wide waist that centers the device and fills the ASD for optimal occlusion. The transcatheter delivery makes it the proven standard of care for the occlusion of ASDs.

Amplatzer Multifenestrated Septal Occluder – “Cribriform”

The Amplatzer Multifenestrated Septal “Cribriform” Occluder has a narrow waist, which allows for placement through a central defect, and matched disc diameters, that maximize coverage of multiple fenestrations.

Different ASDs, Same Results

Left: The waist of the Amplatzer Septal Occluder fills the defect for optimal occlusion. Right: The Amplatzer Cribriform Multi-Fenestrated Septal Occluder enables occlusion of the defect by covering the fenestrations with a single device.

Amplatzer Septal Occluder
Amplatzer Septal Occluder

Learn more about Amplatzer Septal Occluders for ASD Closure by visiting the Abbott Structural Heart website.

Ordering Information

Amplatzer Septal Occluder
Model/Reorder Number Waist Diameter (mm) Waist Width (mm) Right Atrial Disc Diameter (mm) Left Atrial Disc Diameter (mm)
9-ASD-004 4 3 12 16
9-ASD-005 5 3 13 17
9-ASD-006 6 3 14 18
9-ASD-007 7 3 15 19
9-ASD-008 8 3 16 20
9-ASD-009 9 3 17 21
9-ASD-010 10 3 18 22
9-ASD-011 11 4 21 25
9-ASD-012 12 4 22 26
9-ASD-013 13 4 23 27
9-ASD-014 14 4 24 28
9-ASD-015 15 4 25 29
9-ASD-016 16 4 26 30
9-ASD-017 17 4 27 31
9-ASD-018 18 4 28 32
9-ASD-019 19 4 29 33
9-ASD-020 20 4 30 34
9-ASD-022 22 4 32 36
9-ASD-024 24 4 34 38
9-ASD-026 26 4 36 40
9-ASD-028 28 4 38 42
9-ASD-030 30 4 40 44
9-ASD-032 32 4 42 46
9-ASD-034 34 4 44 50
9-ASD-036 36 4 46 52
9-ASD-038 38 4 48 54
9-ASD-040 40 4 50 56
Amplatzer Cribriform Multi-Fenestrated Septal Occluder
Model/Reorder Number Right & Left Atrium Disc Diameter (mm) Waist Width (mm)
9-ASD-MF-018 18 3
9-ASD-MF-025 25 3
9-ASD-MF-030 30 3
9-ASD-MF-035 35 3
9-ASD-MF-040 40 3
TriClip Delivery System

rx-only-logo AMPLATZER™ SEPTAL OCCLUDER

 

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 chocardiography (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 OVERINFLATE.
  • 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.

Handling
Store in a dry place.

Procedural

  • 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.
  • 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.
  • Aspirin (for example, 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.
  • If TEE is used, the patient's esophageal anatomy must be adequate for placement and manipulation of the TEE probe.

Post-implant

  • Patients should take appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
  • 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.
  • Clinical follow-up with a cardiologist and echocardiograms are recommended at implant, 1 day post-implant, pre-discharge, and again at 1 week, 1 month, 6 months, and 12 months post-implant. Immediate follow-up with a cardiologist with the onset of any new symptoms suggestive of erosion or impending erosion, and routine clinical follow-up annually thereafter is also recommended.

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 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
  • Tissue erosion
  • Thrombus formation on discs
  • Stroke
  • Valvular regurgitation

rx-only-logo AMPLATZER™ MULTIFENESTRATED SEPTAL OCCLUDER – “CRIBRIFORM”

 

Indications for Use
The AMPLATZER™ Cribriform Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of multifenestrated (cribriform) atrial septal defects (ASD).
Patients indicated for ASD closure have echocardiographic evidence of fenestrated 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 right ventricular enlargement).

Contraindications
The AMPLATZER™ Cribriform Occluder is contraindicated for the following:

  • Treatment of patients with patent foramen ovale (PFO) defects. This device has not been studied in patients with PFO defects
  • Patients known to have extensive congenital cardiac anomaly, which can only be adequately repaired by way of cardiac surgery.
  • Patients known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
  • Patients known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy unless another anti-platelet agent can be administered for 6 months.
  • Patients known to have demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
  • Patients whose size (such as, too small for transesophageal echocardiography (TEE) probe, catheter size, vasculature size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization
  • Any patient where the radius of the device is greater than the distance from the central defect to the aortic root or superior vena cava.

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 last day of the expiration month 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™ Cribriform 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
  • Implantation of this device may not supplant the need for Coumadin in patients with ASD and paradoxical emboli.
  • The use of transthoracic, transesophageal, or intracardiac echocardiographic imaging (TTE, TEE, or ICE) is required.

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. 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.

Handling
Store in a dry place.

Patient Selection
Certain patients may be at higher risk for complications such as tissue erosion and device embolization. If higher risk patients have devices implanted, closer follow-up is warranted (see “Post-procedure Instructions” on page 9). Higher risk patients include the following:

  • Patients with deformation of the device at the aortic root
  • Patients with high defects (minimal aortic and superior rims)
  • Patients with less than a 9-mm distance from the central defect to the aortic root or superior vena cava orifice

Procedural

  • 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.
  • 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.
  • Aspirin (for example, 81 mg or 325 mg) or an alternative antiplatelet/anticoagulant is recommended to be started at least 24 hours prior to the procedure.
  • Maintain a recommended minimum active clotting time (ACT) of 200 seconds prior to device insertion and throughout the procedure.
  • If TEE is used, the patient's esophageal anatomy must be adequate for placement and manipulation of the TEE probe.

Post-implant

  • Patients should take appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
  • 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.

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 Conditional
Through nonclinical testing, the AMPLATZER™ Septal Occluder has been shown 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 Bl of 118 μT. The AMPLATZER™ Septal Occluder should not migrate in this MR environment. The 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 may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

Adverse Events
Observed Adverse Events – Tissue Erosion/Perforation

The reported incidence of tissue erosion/perforation is approximately 1 in 1,000 patients treated with the AMPLATZER™ Septal Occluder. Tissue erosion, while rare, has led to cardiac tamponade and death. Tissue erosion/perforation refers to the erosion or abrasion of the tissue of the atrium primarily in the area of the roof of the atrium near the aorta.

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
  • Brachial plexus injury
  • Cardiac perforation
  • Death
  • Device collapse due to structural failure
  • Device embolization
  • Device removal (due to embolization or misplacement)
  • Erosion
  • Fever
  • Headache/migraines
  • Hematoma/pseudoaneurysm including blood loss requiring transfusion
  • Hypertension; hypotension
  • Infection including endocarditis
  • Infectious endocarditis
  • Pericardial effusion
  • Perforation of vessel or myocardium
  • Phrenic nerve injury
  • Stroke/transient ischemic attack
  • Thrombus formation on the device surface with the risk of subsequent embolization
  • Valvular regurgitation
  • Vascular access site complications

MAT-2006763 v1.0

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.

False
accessibility
© 2019 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

accessibility

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.