The Cardioform ASD Occluder (Gore Medical) has received US Food and Drug Administration (FDA) premarket approval (PMA) for use in the percutaneous closure of ostium secundum atrial septal defects (ASDs). A press release from the company says that the FDA approval was supported by data collected from the pivotal stage of the Gore ASSURED clinical study which demonstrated 100% closure success at six-months in patients with a successful implant.
The press release also outlines the properties of the Cardioform ASD Occluder, which has an anatomically adaptable waist that conforms to the defect to close ASDs from 8–35 mm in diameter, including those without a retro-aortic rim, by facilitating optimal tissue ingrowth while maintaining thromboresistance. Gore Medical says that as the company’s latest extension to the Gore Cardioform Occluder family it builds on a legacy of safety outcomes.
The Gore ASSURED clinical study, says the company, met its safety, closure, and technical success primary endpoints. It evaluated the safety and efficacy of ASD closure using the Gore Cardioform ASD Occluder in 125 patients with evidence of right heart volume overload demonstrating the need for defect closure. Patients were aged between two and 84 years in 22 investigation sites, including 15 children’s hospitals.
In the press release, Matthew J Gillespie (Children’s Hospital of Philadelphia, Pennsylvania, USA), co-principal investigator of the ASSURED study, says: “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.”