Gore CARDIOFORM ASD Cleared in Europe for Atrial Septal Defects
Gore won the European CE Mark for its GORE CARDIOFORM ASD Occluder, a device designed […]
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
Original Article: (https://www.medgadget.com/2019/10/gore-cardioform-asd-cleared-in-europe-for-atrial-septal-defects.html)