CARDIOVASCULAR
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AMPLATZER™ Septal Occluder

AMPLATZER™ Septal Occluder

PRODUCT HIGHLIGHTS

  • Self-expanding, double-disc device designed for closure of atrial septal defects
  • Self-centering waist fills the defect
  • Device can be easily recaptured and redeployed for optimal placement
  • Nitinol and interwoven polyester promote occlusion and tissue in-growth
  • Safe and efficacious: 97.2% closure rate at 6 months1; 1.6% major adverse events2

ORDERING INFORMATION

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
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AMPLATZER™ Septal Occluder

1. AMPLATZER Septal Occluder Pivotal Trial – Closure rate at 6 months defined as a shunt less than or equal to 2 mm without the need for surgical repair.

2. AMPLATZER Septal Occluder Pivotal Trial – Major adverse events at 12 months defined as events that are life threatening, prolong hospitalization or have long-term consequences or need for ongoing therapy.


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.

100033292 – May 2012

Last Updated: January 02, 2019

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