The U.S. Food and Drug Administration has granted premarket approval for the GORE Gore Carioform ASD Occluder for treating heart defects.
The FDA approval was supported by data collected from a clinical study which demonstrated 100 percent closure success at the six-month evaluation in patients with a successful implant.
The study evaluated the safety and efficacy of ASD closure 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 FDA approval of the GORE Gore Carioform ASD Occluder Occluder is a significant milestone for innovation in the minimally invasive treatment of ASDs,” said Matthew J. Gillespie, M.D., Children’s Hospital of Philadelphia, co-principal investigator of the ASSURED Study. “This soft, conformable device was not previously available for this range of defects but is now an option for larger defects that typically have a greater risk for complications, including right heart enlargement, atrial fibrillation, and pulmonary hypertension. The ability to retrieve and reposition the GORE Gore Carioform ASD Occluder helps me ensure proper positioning and offers me confident closure.”
“We developed the GORE Gore Carioform ASD Occluder in partnership with leading interventional cardiologists around the globe, and its design is informed by decades of experience in technological innovation and dedication to improving patient care,” said Jake Goble, Gore Structural Heart Pipeline Leader. “This new addition extends what physicians can achieve with the Gore Cardioform family.”
Gore Medical is based in Flagstaff, AZ and is the fastest-growing business at the materials science company based in Newark. Gore employs 9,500 Associates and generates annual revenues of $3.5 billion.