The new occluder, which can repair both small and large cardiovascular defects, received premarket approval.
WL Gore and Associates has announced that their Cardioform ASD Occluder, which enables percutaneous closure of ostium secundum atrial septal defects (ASDs), received premarket approval from the US Food and Drug Administration (FDA).
The approval of the device is based on the results of the ASSURED clinical trial, which demonstrated 100% closure success at 6 months of 125 patients, between the ages of 2 and 84, whose right heart volume overload was repaired with the occluder. The ASSURED study met the clinical safety and efficacy endpoints, while demonstrating 100% closure success at the 6-month evaluation mark.
"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, MD, of Children's Hospital of Philadelphia, the co-principal investigator of the ASSURED study.
The Cardioform ASD Occluder is capable of conforming to larger defects—such as right heart enlargement, atrial fibrillation, or pulmonary hypertension—that are statistically at greater risk of complications. The occluder’s anatomic adaptable waist enables it to work for both small and large defects, ranging from 8 to 35 mm in diameter. Additionally, the device does not require a retro-aortic rim in order to successful repair a cardiovascular defect. The repair is completed by facilitating optimal tissue ingrowth while maintaining thromboresistance.
“We developed the GORE CARDIOFORM ASD Occluder in partnership with leading interventional cardiologists around the globe, and its design is informed by decades of experience in technological innovation and dedication to improving patient care,” said Jake Goble, MBA, PhD, heart pipeline leader at Gore, in a statement. "This new addition extends what physicians can achieve with the GORE CARDIOFORM Occluder family."
The new Cardioform ASD Occluder joins the ranks of GORE’s previous releases, such as the Cardioform Septal Occluder. The septal occluder, which received FDA approval in May 2018, repairs defects up to 17 mm, including foramen ovale (PFO) closure to prevent recurrent ischemic stroke.