W. L. Gore & Associates has completed enrolling first patient in a clinical trial of its GORE Septal Occluder, designed for the percutaneous, trancatheter closure of ostium secundum atrial septal defect (ASD).
The device features a five-wire support frame and a thin, conformable membrane patch-like EPTFE material to improve closure performance and provide an open microstructure for controlled tissue ingrowth.
The multicenter, prospective, single-arm study is designed to asses the safety and efficacy of Septal Occluder and compare it with the outcomes from previous GORE HELEX Septal Occluder clinical studies.
The company said the study will also collect six months post-procedure patient data and will continue to monitor patients for three years from 50 patients at 11 investigational sites.
Congenital Heart Center chief John Rhodes said, "The Gore device has an exceptional design that makes it easy to deploy, and the innovative ePTFE material conforms to the heart for optimal patient outcomes."
In addition to ASD, the Septal Occluder is CE marked for the indication of patent foramen ovale.