Therapy Areas: Devices
Gore announces US FDA PMA for the GORE CARDIOFORM ASD Occluder to treat atrial septal defects
5 June 2019 -

Materials science company W. L. Gore & Associates (Gore) revealed on Tuesday that it has received US Food and Drug Administration (FDA) premarket approval (PMA) for the GORE CARDIOFORM ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects (ASDs), a hole in the wall (septum) between the two upper chambers of the heart (the atria).

The company disclosed that the GORE CARDIOFORM ASD Occluder's anatomically adaptable waist conforms to the defect to close ASDs from 8 mm to 35 mm in diameter, including those without a retro-aortic rim, by facilitating optimal tissue ingrowth, while maintaining thromboresistance.

This US FDA PMA was supported by data collected from the company's pivotal stage of the Gore ASSURED Clinical Study patients between the ages of two and 84, across 22 investigation sites, including 15 children's hospitals, demonstrating 100% closure success at the six month evaluation. The 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.

In conjunction, the Gore ASSURED Clinical Study pivotal study met its safety, closure and technical success primary endpoints, added the company.

In addition, the US FDA approval for the GORE CARDIOFORM Septal Occluder was supported by positive results from the Gore REDUCE Clinical Study, which demonstrated its safety and efficacy with a Gore device plus antiplatelet therapy compared to antiplatelet therapy alone in patients with a PFO, revealed the company.