HX2015

Gore Helex Septal Occluder, 15mm

$470.00 box of 1

Out of stock

Expiration: Expired

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The item listed above is expired and may be used for educational, training, and non-clinical research purposes only. Any product information appearing below, including the product indication statement, pertains to an in-date item only.

Description

GORE® HELEX® Septal Occluder

The GORE® HELEX® Septal Occluder is a permanently implanted prosthesis and catheter delivery system indicated for the transcatheter closure of ostium secundum atrial septal defects (ASDs). The pre-assembled delivery system allows easy deployment of the device via standard femoral venous access.

The Occluder, which is composed of ePTFE patch material supported by a single nitinol wire frame, bridges and eventually occludes the septal defect to stop the shunting of blood between the atria. Over the course of several weeks to months, cells begin to infiltrate and grow over the ePTFE membrane, ensuring successful closure of the defect.

Additional information

Size

15.00mm

Arms

N/A

Manufacturer

Unit

box of 1

  • FDA Product Code: MLV
  • FDA Product Code Name: Transcatheter septal occluder
  • GMDN Term Code: 45418
  • GMDN Term Name: Cardiac defect occluder
  • GMDN Term Description: An implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.

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