GORE CARDIOFORM Approved by FDA to Treat Atrial Septal Defects

The GORE CARDIOFORM ASD Occluder has been approved by the FDA to treat ostium secundum atrial septal defects (ASD) via percutaneous closure procedures.

In a clinical study of the device in 125 patients with ASD, ranging in age from 2 to 84, all who successfully received the implant maintained the closure when evaluated six months later.The GORE CARDIOFORM is made of two discs that make contact with the tissue walls on both sides of the opening and, when activated, come together to block the passage of blood between the atria. It was approved by the FDA last year for patent foramen ovale closures, as a way of reducing the chances of ischemic stroke.

In terms of ASD, it can treat openings between 8 mm and 35 mm in diameter, including those without a retro-aortic rim. It lets native tissue grow into itself, facilitating healing.

“The FDA approval of the GORE CARDIOFORM ASD Occluder is a significant milestone for innovation in the minimally invasive treatment of ASDs,” said Matthew J. Gillespie, M.D., Children’s Hospital of Philadelphia, co-principal investigator of the ASSURED Study that evaluated the device for ASD closures. “This soft, conformable device was not previously available for this range of defects but is now an option for larger defects that typically have a greater risk for complications, including right heart enlargement, atrial fibrillation, and pulmonary hypertension. The ability to retrieve and reposition the GORE CARDIOFORM ASD Occluder helps me ensure proper positioning and offers me confident closure.”