Gore won the European CE Mark for its GORE CARDIOFORM ASD Occluder, a device designed for percutaneous, transcatheter closure of ostium secundum atrial defects (ASDs). The occluder recently completed a clinical study involving 125 patients with ASD, ranging from 2 to 84 years of age, all of whom were successfully implanted with the GORE CARDIOFORM ASD and maintained closure six months later.
The device is made of two discs that make contact with the tissue walls on both sides of the opening and, when engaged, come together to block the passage of blood between the atria. It was recently approved by the FDA for ASD, as well as for patent foramen ovale closures as a way of reducing the chances of ischemic stroke.
The implant can be used to treat openings between 8 mm and 35 mm in diameter, including those without a retro-aortic rim. It lets native tissue grow into itself, further facilitating healing. “Larger defects typically have a greater risk for complications, like pulmonary hypertension, right heart enlargement, or atrial fibrillation. But previously, Europe didn’t have access to the GORE CARDIOFORM ASD Occluder for this range of defects,” said Matthew Gillespie, M.D., Children’s Hospital of Philadelphia, co-principal investigator of the ASSURED Clinical Study, in a Gore press release. “CE Mark makes this soft, conformable device available for the minimally invasive treatment of a broader range of ASDs.”
Product page: GORE CARDIOFORM Septal Occluder
Flashbacks: GORE CARDIOFORM Approved by FDA to Treat Atrial Septal Defects; GORE CARDIOFORM Septal Occluder Approved by FDA for PFO Closure
Via: Gore