The Gore Cardioform ASD Occluder has received the CE mark. A press release reports that the device offers physicians a clinically proven design in a device that, in a recent study, met its primary endpoint for the percutaneous, transcatheter closure of ostium secundum atrial defects (ASDs). It adds that the Gore ASSURED clinical study demonstrated safety, closure, and technical success that statistically achieved the primary endpoint.
According to the press release, the Cardioform ASD Occluder’s anatomically adaptable waist conforms to the defect to close ASDs from 8mm to 35mm in diameter—including those without a retro-aortic rim—by facilitating optimal tissue ingrowth while maintaining thromboresistance. Additionally, the ability to retrieve and reposition the Gore Cardioform ASD Occluder helps ensure proper positioning and offers physicians confident closure.
A pivotal study 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. The study involved patients between the ages of two and 84, across 22 investigation sites, including 15 children’s hospitals. It met its safety, closure, and technical success primary endpoints.
Matthew Gillespie (Division of Cardiology, The Children’s Hospital of Philadelphia, Philadelphia, USA), co-principal investigator of the ASSURED clinical study, says: “Larger defects typically have a greater risk for complications, like pulmonary hypertension, right heart enlargement, or atrial fibrillation. But previously, Europe did not 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 press release states that the FDA recently approved the Cardioform ASD Occluder for the treatment of atrial septal defects and is the newest addition in Gore’s Occluder portfolio. The portfolio also includes the Cardioform Septal Occluder, which is indicated for ASD closure for defects up to 17 mm and received FDA approval in 2018 for patent foramen ovale (PFO) closure to prevent recurrent ischaemic stroke.