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STRUCTURAL INTERVENTIONS

AMPLATZER™ SEPTAL OCCLUDER CLINICAL DATA

The primary treatment option for atrial septal defects (ASD) is percutaneous, transcatheter closure, and the Amplatzer™ Septal Occluder is the proven standard of care1,2—with more than 20 years of global clinical experience in ASD closure.3

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

The Amplatzer™ Septal Occluder is the most studied transcatheter atrial septal defect (ASD) closure device available today

U.S. PIVOTAL TRIAL: LOWER RATES OF ADVERSE EVENTS VS SURGERY2

This study was conducted to determine the safety and efficacy of transcatheter ASD closure involving 442 device-closure patients and 911.5 total patient-years of device experience.2 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
 
AMPLATZERTM SEPTAL OCCLUDER PATIENTS
Procedure Attempt Success95.7%
Immediate Procedure Success97.6%
24-hour closure rate96.7%
6-month closure rate97.2%
12-month closure rate98.5%
Major complications1.6%
Minor complications6.1%

AMPLATZER SEPTAL OCCLUDER POST-APPROVAL STUDY3

  • Read more

    This study is evaluating the long-term safety and efficacy of the Amplatzer Septal Occluder. The results below are from 1,000 patients reported in July 2011.3

    Procedural success rate97.9%
    One-month closure rate98.5%
    Two-year closure rate97.9%

MAGIC ATRIAL SEPTAL DEFECT STUDY4

  • Read more

    This study evaluated the initial safety and results of unrestricted multi-institution routine use of the Amplatzer Septal Occluder in 478 patients.4

    Procedural success rate96%
    24-hour closure rate99%
Abbott Amplatzer Portfolio App helps physicians determine which structural intervention device to use

NEW VERSION AVAILABLE
GET THE AMPLATZER PORTFOLIO APP

The Amplatzer Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.
 

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MAT-2115553 v2.0 | Item approved for U.S. use only.

References
  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. Du ZD, Hijazi ZM, Kleinman CS, Silverman NH, Larntz K; Amplatzer Investigators. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol. 2002;39:1836-1844. doi: 10.1016/S0735-1097(02)01862-4.
  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.
Important Safety Information

Rx Only

AMPLATZER™ SEPTAL OCCLUDER AND DELIVERY SYSTEM

INDICATION 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.

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.

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