W.L. Gore & Associates said today that it won FDA premarket approval for its Gore Cardioform ASD occluder designed for the percutaneous closure of ostium secundum atrial septal defects.
Approval came supported by data from the pivotal stage of Flagstaff, Ariz.-based Gore’s ASSURED clinical study, which reported a 100% closure success rate at six months post-implant.
Investigators in the ASSURED trial explored the safety and efficacy of atrial septal defects using the Cardioform ASD occluder in 125 patients with evidence of right heart volume overload demonstrating the need for defect closure. The trial met its safety, closure and technical success primary endpoints, Gore said.
“The FDA approval of the Gore Cardioform ASD occluder is a significant milestone for innovation in the minimally invasive treatment of ASDs. 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,” co-principal trial investigator Dr. Matthew Gillespie of the Children’s Hospital of Philadelphia said in a prepared statement.
The Gore Cardioform ASD occluder features an adaptable waist to conform to the defect to close ASDs of between 8mm to 35mm in diameter, including those without a retro-aortic rim. The system is designed to facilitate optimal tissue ingrowth and maintain thromboresistance, Gore said.
“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. This new addition extends what physicians can achieve with the Gore Cardioform occluder family,” Gore structural heart pipeline leader Jake Goble said in a prepared release.
Last month, Gore said that it won a nod from the FDA for its Gore Tag conformable thoracic endovascular aortic repair stent graft with Active Control.