October 2, 2019
Gore's Cardioform ASD Occluder Approved and Launched in Europe
October 2, 2019—Gore & Associates announced CE Mark approval and the European launch of the Cardioform atrial septal defect (ASD) occluder for percutaneous transcatheter closure of ostium secundum ASDs.
According to Gore, the Cardioform ASD occluder’s anatomically adaptable waist conforms to the defect to close ASDs with diameters of 8 to 35 mm, including those without a retroaortic rim, by facilitating optimal tissue ingrowth while maintaining thromboresistance. The ability to retrieve and reposition the device helps ensure proper positioning and offers physicians confident closure.
The recent ASSURED clinical study evaluated the safety and efficacy of ASD closure using the Cardioform device in 125 patients with evidence of right heart volume overload demonstrating the need for defect closure. The study included patients between the ages of 2 and 84, across 22 investigation sites, including 15 children’s hospitals. The pivotal study met its safety, closure, and technical success primary endpoints.
In June 2019, Gore announced that the Cardioform ASD occluder received premarket approval from the FDA for treatment of ASDs in the United States.
Matthew Gillespie, MD, Coprincipal Investigator of the ASSURED clinical study, commented in Gore’s announcement, “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.” Dr. Gillespie is from Children’s Hospital of Philadelphia in Philadelphia, Pennsylvania.