AMPLATZER™ Septal Occluder
CARDIOVASCULAR
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AMPLATZER™ Septal Occluder

AMPLATZER™ Septal Occluder Top Image

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
9-ASD-040 40 4 50 56 12 F; 45° Curve

AMPLATZER™ Septal Occluder Bottom Image

9-ASD-040 Device size not available for sale in the U.S.

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.


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

Product referenced is approved for CE Mark. 40 mm occluder not available for sale in the U.S. Device depicted may not be available in all countries.

GMSH273EN (May 2012)

Last Updated: January 02, 2019

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