Enrollment Completed in Pivotal ASSURED Study of Gore's Cardioform ASD Occluder
September 26, 2017—Gore & Associates announced the completion of enrollment for the pivotal phase of the ASSURED clinical study, which is evaluating the interventional closure of atrial septal defects (ASDs) using Gore's Cardioform ASD occluder (8- to 35-mm sizes).
The prospective study enrolled patients at 22 sites under an investigational device exemption from the US Food and Drug Administration (FDA) to evaluate the safety and effectiveness of the Cardioform ASD occluder in the treatment of ostium secundum ASDs. The pivotal stage of the study includes 125 patients and 3 years of follow-up, with patients being assessed for technical, safety, and closure success at 6 months. Results are expected in mid-2018, which will allow Gore to submit the device for FDA approval.
According to the company, the Cardioform ASD occluder is designed with an anatomically adaptable waist to accommodate the natural anatomy of the heart and mitigate the potential for cardiac injury.
The device is composed of a minimal metal frame covered in Gore’s expanded polytetrafluoroethylene film technology to facilitate tissue ingrowth that permanently closes ASDs. The new Cardioform ASD occluder will complement the existing Cardioform septal occluder, which can treat ASDs up to 17 mm in diameter, and will be able treat a broader range of ASDs with a soft, conformable device design in five sizes.
Robert Sommer, MD, and Matthew Gillespie, MD, serve as Coprincipal Investigators of the ASSURED study. In the company's press release, Dr. Gillespie commented, “The Gore Cardioform ASD occluder represents an exciting innovation in the endovascular treatment of larger ASDs. The larger the defect, the greater the risk for complications, which makes the repair of larger ASDs imperative. As we consider closure of large ASDs today, we must be mindful of the potential risks associated with the long-term interaction of the device with the heart. Completion of enrollment brings us one step closer toward having a unique conformable alternative for the closure of large ASDs, potentially reducing the risk of cardiac injury for these patients.”