GORE HELEX Septal Occluder Designed to Treat Atrial Septal Defects


March 4, 2009

The GORE HELEX Septal Occluder was approved by the FDA in 2006 for the treatment of atrial septal defects (ASD), a congenital heart defect. The GORE HELEX Septal Occluder is the first device of its kind to use ePTFE, a biocompatible material that allows progressive tissue ingrowth, to help seal the defect. The device is permanently implanted in a minimally invasive procedure through a catheter-based delivery system.

In December 2008, the GORE HELEX Septal Occluder became part of an FDA-approved clinical study designed to demonstrate the safety and effectiveness of the device for patent foramen ovale (PFO) closure in patients with a PFO and history of cryptogenic stroke.