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Gore Receives CE Mark for the GORE® CARDIOFORM ASD Occluder for the Treatment of Atrial Septal Defects in Europe

CE Mark supported by data from the Gore ASSURED Clinical Study, demonstrating 100 percent closure success

FLAGSTAFF, Ariz. – October 2, 2019 – W. L. Gore & Associates (Gore) has introduced the newest member of its family of occluders, the GORE® CARDIOFORM ASD Occluder, which has received CE Mark. 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).

The Gore ASSURED Clinical Study demonstrated safety, closure, and technical success that statistically achieved the primary endpoint. The new addition to the Gore portfolio extends what physicians can achieve with the GORE CARDIOFORM Occluder family.

The GORE 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. The ability to retrieve and reposition the GORE CARDIOFORM ASD Occluder helps ensure proper positioning and offers physicians confident closure.

“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,” said Matthew Gillespie, M.D., Children’s Hospital of Philadelphia, co-principal investigator of the ASSURED Clinical Study. “CE Mark makes this soft, conformable device available for the minimally invasive treatment of a broader range of ASDs.”

The 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 2 and 84, across 22 investigation sites, including 15 children's hospitals. The pivotal study met its safety, closure, and technical success primary endpoints.

“As the latest extension of the GORE CARDIOFORM Occluder family, the GORE CARDIOFORM ASD Occluder builds on a legacy of safety,” said Jake Goble, M.B.A, Ph.D., Gore Structural Heart Pipeline Leader. “Leading interventional cardiologists worldwide informed its development, and its design builds on decades of clinical experience and manufacturing excellence.”

The GORE CARDIOFORM ASD Occluder was recently granted approval by the U.S. Food and Drug Administration for the treatment of atrial septal defects and is the newest addition in Gore’s occluder portfolio.* The portfolio also includes the GORE® CARDIOFORM Septal Occluder, which is indicated for ASD closure for defects up to 17 mm and received U.S. Food and Drug Administration approval in 2018 for patent foramen ovale (PFO) closure to prevent recurrent ischemic stroke. In May 2018, positive results were announced from the Gore REDUCE Clinical Study, which demonstrated the safety and efficacy of PFO closure with a Gore device plus antiplatelet therapy compared to antiplatelet therapy alone in patients with a PFO and history of cryptogenic stroke.

*For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).

MEDICAL PRODUCTS DIVISION

Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health conditions. With more than 40 million medical devices implanted over the course of more than 40 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use, and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians, and through this collaboration we are improving lives. www.goremedical.com

ABOUT W. L. GORE & ASSOCIATES

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments — from revolutionizing the outerwear industry with GORE-TEX® fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. The company is also known for its strong, team-oriented culture and continued recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs approximately 10,000 Associates and generates annual revenues that exceed $3.5 billion. www.gore.com