Amplatzer™ Septal Occluder


Greater Safety Compared with Surgical Closure

The Amplatzer™ Septal Occluder is the most studied transcatheter atrial septal defect (ASD) closure device available today, with over 20 years of demonstrated clinical experience.1,2

The following three studies, together, cover over 1,500 patient-years of device experience.2-4

Greater Safety Compared with Surgical Closure

The Amplatzer™ Septal Occluder is the most studied transcatheter atrial septal defect (ASD) closure device available today, with over 20 years of demonstrated clinical experience.1,2

The following three studies, together, cover over 1,500 patient years of device experience.2-4


U.S. Pivotal Trial: Lower Rates of Adverse Events vs Surgery2

The U.S. Pivotal Trial revealed:

  • An adverse event rate 3 times lower for Amplatzer Septal Occluder as compared to surgical closure.
  • No erosion events
12-month closure rate*98.5%100%
Major adverse events 1.6%5.2%
Minor adverse events6.1%18.8%

* A shunt ≤ 2 mm without the need for surgical repair
† Events that are life threatening, prolong hospitalization, or have long-term consequences or need for ongoing therapy
‡ Device embolization with percutaneous retrieval, cardiac arrhythmia with treatment, phrenic nerve injury, hematoma, other procedural adverse events, pericardial effusion requiring medical management, evidence of device associated thrombus formation without embolization (with or without treatment), marker band embolization without known sequelae
§ Mean age of Amplatzer™ Septal Occluder group 18 years; 6 years for surgical closure group

Amplatzer™ Septal Occluder Post-Approval Study3

The 2-year follow-up data are as follows:

  • Successful closure rate of 97.9%
  • MAGIC Atrial Septal Defect Study4

    Procedure success rate*96%
    24-hour closure rate99.6%
    Major adverse events1.1%
    Minor adverse events§4.8%

    * Successful occluder implantation
    † Defined as no to a small residual shunt
    ‡ Includes device embolization with surgical removal
    § Includes procedure-related arrhythmias, device embolization with percutaneous retrieval, heparin over-dosage that required reversal, asymptomatic thrombus in the pulmonary artery that resolved with heparin therapy over 24 hours

  • Costs with Transcatheter ASD Closure vs Surgical Closure9

    One retrospective review study evaluated both hospital costs as well as wage loss for parents of pediatric patients between surgical vs transcatheter ASD closure.

    Length of stay (days)1.3 ± 1.33.6 ± 1.6< 0.001
    Total charges$64,966 ± 30,275$90,000 ± 43,771< 0.001
    Wage loss$857 ± 173$2,536 ± 222< 0.001

    The authors noted that because technical proficiency with the transcatheter approach continues to improve, procedure times and radiation exposure are decreasing. Some centers perform catheter-based ASD closure with increasing reliance on echocardiographic guidance.

MAT-2008369 v1.0 | Item approved for U.S. use only.

  1. Masura J, Gavora P, Formanek A, et al. Transcatheter closure of secundum atrial septal defects using the new self-centering Amplatzer septal occluder: initial human experience. Cathet Cardiovasc Diagn. 1997;42:388-393.
  2. Amplatzer Septal Occluder IFU.
  3. Turner DR, Owada CY, Sang II CJ, et al. Closure of secundum atrial septal defects with the Amplatzer Septal Occluder: a prospective, multicenter, post-approval study. Circ Cardiovasc Interv. 2017;10:e004212.
  4. Everett AD, Jennings J, Sibinga E, et al. Community use of the Amplatzer atrial septal defect occluder: results of the multicenter MAGIC atrial septal defect study. Pediatr Cardiol. 2009;30:240-247.
  5. DiBardino DJ, McElhinney DB, Kaza AK, et al. Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database. J Thorac Cardiovasc Surg. 2009;137(6):1334-1341.
  6. Karamlou T, Diggs BS, Ungerleider RM, et al. The rush to atrial septal defect closure: is the introduction of percutaneous closure driving utilization? Ann Thorac Surg. 2008;86:1584–1591.
  7. Kazmouz S, Kenny D, Cao Q-L, et al. Transcatheter closure of secundum atrial septal defects. J Invasiv Cardiol. 2013;25:257-264.
  8. Crawford GB, Brindis RG, Krucoff MW, et al. Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature. Catheter Cardiovasc Interv. 2012;80(2):157-167. doi: 10.1002/ccd.24347.
  9. Sanchez JN, Seckeler MD. Lower hospital charges and societal costs for catheter device closure of atrial septal defects. Pediatr Cardiol. 2017;38:1365–1369. doi: 10.1007/s00246-017-1671-0.
Important safety information


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).


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.


  • 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.


  • 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 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

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