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AMPLATZER™ Septal Occluder

AMPLATZER Septal Occluder (ASO) is designed for minimally-invasive atrial septal defect (ASD) closure.1 This double-disc occluder is comprised of Nitinol mesh with polyester fabric. The ASO is designed to appose the septal wall on each side of the defect and create a platform for tissue in-growth after implantation.

amplatzer-septal-occluder
Overview

When Simplicity Matters

The primary treatment option for closure of secundum atrial septal defects is with transcatheter devices.2 This is when trust and simplicity matter. The AMPLATZER Septal Occluder is the proven standard of care in transcatheter atrial septal defect closure1, 2

Safety in Numbers
  • 98.5% Closure Rate: With no significant residual shunt (less than 2 mm) at 1-year follow-up1
  • Low Major and Minor Complication Rates: Post-procedure and long-term based on 5-year follow-up1
Specifically Designed for ASD Closure
  • Wide Waist: Centers device and fills the ASD
  • Shape-memory Nitinol Mesh: Designed to securely appose both sides of the septal wall
  • Polyester Material: Promotes occlusion and tissue in-growth
  • Precise Placement: Device can be easily recaptured and redeployed

AMPLATZER Septal Occluders Procedural Video

Watch the following product demonstrations to understand how AMPLATZER Septal Occluders are prepared, delivered and can be repositioned for precise placement.

The primary treatment option for closure of secundum atrial septal defects is with transcatheter devices.2 The AMPLATZER Septal Occluder (ASO) is designed for minimally-invasive atrial septal defect (ASD) closure.1 Watch the following product demonstrations to understand how AMPLATZER Septal Occluders are prepared, delivered and can be repositioned for precise placement.


References

1 AMPLATZER Septal Occluder Instructions for Use.
2 Kashour, TS, Latroche, B, Elhoury, ME, Galal, MO. Successful Percutaneous Closure of a Secundum Atrial Septal Defect through Femoral Approach in a Patient with Interrupted Inferior Vena Cava. Congenital Heart Disease. 2010;5(6):620-623.

Tech Specs

AMPLATZER™ Septal Occluder

Ordering Information   View Catalog   

Contents: 1 occluder

Reorder Number Device Size/ Waist Diameter (mm) Waist Length (mm) Right Atrial Disc Diameter (mm) Left Atrial Disc Diameter (mm) Min. Recommended Sheath Size (AMPLATZER™ TorqVue™ Delivery System)
9-ASD-004 4 3 12 16 6 F; 45° Curve
9-ASD-005 5 3 13 17 6 F; 45° Curve
9-ASD-006 6 3 14 18 6 F; 45° Curve
9-ASD-007 7 3 15 19 6 F; 45° Curve
9-ASD-008 8 3 16 20 6 F; 45° Curve
9-ASD-009 9 3 17 21 6 F; 45° Curve
9-ASD-010 10 3 18 22 6 F; 45° Curve
9-ASD-011 11 4 21 25 7 F; 45° Curve
9-ASD-012 12 4 22 26 7 F; 45° Curve
9-ASD-013 13 4 23 27 7 F; 45° Curve
9-ASD-014 14 4 24 28 7 F; 45° Curve
9-ASD-015 15 4 25 29 7 F; 45° Curve
9-ASD-016 16 4 26 30 7 F; 45° Curve
9-ASD-017 17 4 27 31 7 F; 45° Curve
9-ASD-018 18 4 28 32 8 F; 45° Curve
9-ASD-019 19 4 29 33 8 F; 45° Curve
9-ASD-020 20 4 30 34 9 F; 45° Curve
9-ASD-022 22 4 32 36 9 F; 45° Curve
9-ASD-024 24 4 34 38 9 F; 45° Curve
9-ASD-026 26 4 36 40 10 F; 45° Curve
9-ASD-028 28 4 38 42 10 F; 45° Curve
9-ASD-030 30 4 40 44 10 F; 45° Curve
9-ASD-032 32 4 42 46 12 F; 45° Curve
9-ASD-034 34 4 44 50 12 F; 45° Curve
9-ASD-036 36 4 46 52 12 F; 45° Curve
9-ASD-038 38 4 48 54 12 F; 45° Curve

Evidence

The AMPLATZER Septal Occluder is the most studied intracardiac, percutaneous device in the marketplace today with over 15 years of demonstrated clinical experience.1,2 The following three studies cover over 1,500 patient years of device experience.1-3

US Pivotal Study1 (1998-2001)

This study was conducted to determine the safety and efficacy of transcatheter atrial septal defect closure involving 442 device closure patients and 911.5 total patient years of device experience.

Study Outcome
AMPLATZER Septal Occluder
Patients
Surgical Control
Patients
P-value
Procedural Success Ratea  97.6% 100% (-0.059, +0.008)
24-hour Closure Rateb  96.7% 100% (-0.068, +0.003)
6-month Closure Rateb  97.2% 100% (-0.068, +0.003)
12-month Closure Rateb  98.5% 100% (-0.052, +0.017)
Major Adverse Eventsc  1.6% 5.2% 0.030
Minor Adverse Eventsd  6.1% 18.8% <0.001

a. Successful closure of the defect as measured immediately following the procedure (less than or equal to a 2 mm residual shunt).
b. Defined as a shunt less than or equal to 2 mm without the need for surgical repair.
c. Events that are life threatening, prolong hospitalization or have long-term consequences or need for ongoing therapy.
d. 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 sequlae.

 

AMPLATZER Septal Occluder Post-Approval Study2 (2008-Today)

This study is evaluating long-term safety and efficacy; results from 564 patients reported in July 2011. As of the reported timeframe, there were >625 patient years of device experience.

Interim Resultsa
Technical Success Rateb 98.4%
1-month Closure Ratec 96.8%
Non-serious Adverse Events that were Device or Product Related 1.8%
Serious Adverse Events that were Device or Delivery System Related 0.4%
Patient Follow-up Rate >93%

a. AMPLATZER Septal Occluder Interim Post Market Approval Study Results as presented on July 23, 2011 by Dr. Thomas Forbes at PICS-AICS.
b. Successful deployment of the device percutaneously.
c. Defined as a shunt less than or equal to 2 mm as assessed by Echo without the need for surgical repair.

 

MAGIC Atrial Septal Defect Study3 (2004-2007)

This study was designed to evaluate the initial safety and results of unrestricted multi-institution routine use of the AMPLATZER Septal Occluder in 478 patients.

Study Outcome
Procedure Success Ratea 96%
24-hour Closure Rateb 99.6%
Major Adverse Eventsc 1.1%
Minor Adverse Eventsd 4.8%

a. Successful AMPLATZER Septal Occluder implantation.
b. Defined as no to a small residual shunt.
c. Includes device embolization with surgical removal.
d. Includes procedure related arrhythmias, device embolization with percutaneous retrieval, heparin overdosage that required reversal, asymptomatic thrombus in the pulmonary artery that resolved with heparin therapy over 24 hours.


References

1 AMPLATZER Septal Occluder Instructions for Use.
2 Forbes T. Interim results of the Amplatzer septal occluder post approval study. Presented at PICS-AICS, July 23, 2011, Boston, MA.
3 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(3):240-7.

Indications, Safety & Warnings
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Rx Only

Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.