GORE HELEX Septal Occluder Designed to Treat Atrial Septal Defects
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.