News | October 28, 2019

Gore Receives European Approval For Cardioform ASD Occluder For Atrial Septal Defects

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

The Gore Cardioform ASD Occluder received European CE mark clearance in early October. The device offers a percutaneous, transcatheter closure option for the ostium secundum atrial septal defects (ASDs).

October 28, 2019 — The Gore Cardioform ASD Occluder received European CE mark clearance in early October. The device offers a percutaneous, transcatheter closure option for the ostium secundum atrial septal 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 the Gore Cardioform occluder family.

The ASD occluder’s anatomically adaptable waist conforms to the defect to close ASDs from 8 to 35 mm in diameter, including those without a retro-aortic rim, by facilitating optimal tissue ingrowth, while maintaining thrombo-resistance. The ability to retrieve and reposition the Ccardioform ASD Occluder helps ensure proper positioning and offers confident closure, the vendor said.

“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 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.

The Cardioform ASD Occluder was recently granted approval by the U.S. Food and Drug Administration (FDA) 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 clearance 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 more information: www.gore.com

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