CARDIOVASCULAR
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AMPLATZER™ PI Muscular VSD Occluder

AMPLATZER™ PI Muscular VSD Occluder
AMPLATZER™ PI Muscular VSD Occluder

PRODUCT HIGHLIGHTS

  • Self-expanding, double-disc device designed for closure of muscular ventricular septal defects
  • The 10 mm waist length accommodates the damaged muscular tissue of the ventricular septal wall of myocardial infarction patients
  • Symmetrical design allows a venous or arterial delivery approach
  • Device can be easily recaptured and redeployed for optimal placement
  • Nitinol and interwoven polyester promote occlusion and tissue in-growths

ORDERING INFORMATION


Reorder Number Device Size/ Waist Diameter (mm) Disc Diameter (mm) Waist Length (mm) Min. Recommended Sheath Size (AMPLATZER™ TorqVue™ Delivery System)
9-VSDMPIHDE-016 16 26 10 9 F, 45° or 180° Curve
9-VSDMPIHDE-018 18 28 10 9 F, 45° or 180° Curve
9-VSDMPIHDE-020 20 30 10 10 F, 45° Curve
9-VSDMPIHDE-022 22 32 10 10 F, 45° Curve
9-VSDMPIHDE-024 24 34 10 10 F, 45° Curve
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The PIVSD is a Humanitarian Use device. Authorized by federal law for use in the treatment of muscular ventricular septal defects (VSDs) in patients with acute myocardial infarction. The effectiveness of this device for this use has not been demonstrated.

AMPLATZER™ TorqVue™ 45° or 180° Delivery Systems are recommended for use with the AMPLATZER™ PI VSD Occluder.


Rx Only

 

Brief Summary: 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.

 

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies. © 2017 St. Jude Medical, LLC. All Rights Reserved.

SJM-PIVSD-0117-0005

Last Updated: January 02, 2019

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