The Gore Cardioform Occluder for atrial septal defects (ASD) has received CE mark in Europe, the company has announced, stating that the move was supported by data from the Gore ASSURED clinical study.
In its press release, Gore points out that the Cardioform ASD Occluder has an anatomically adaptable waist that conforms to the defect to close ASDs from 8–35mm in diameter, including those without a retro-aortic rim, by facilitating optimal tissue ingrowth, while maintaining thromboresistance. The ability to retrieve and reposition the occluder helps to ensure proper positioning and offers physicians confident closure, it says.
ASSURED demonstrated safety, closure, and technical success that statistically achieved the primary endpoint of percutaneous, transcatheter closure of ostium secundum ASDs. It evaluated the safety and efficacy of ASD closure using the Cardioform ASD Occluder in 125 patients with evidence of right heart volume overload demonstrating the need for defect closure. The study involved patients between the ages of two and 84, across 22 investigation sites, including 15 children’s hospitals.
Matthew Gillespie (Children’s Hospital of Philadelphia, Philadelphia, USA), coprincipal investigator of the ASSURED study, commented in the press release: “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. CE mark makes this soft, conformable device available for the minimally invasive treatment of a broader range of ASDs.”
The Cardioform ASD Occluder was recently granted approval by the US Food and Drug Administration (FDA) for the treatment of atrial septal defects and is the newest addition in Gore’s occluder portfolio.