W. L. Gore & Associates has enrolled the first patient in its GORE Septal Occluder clinical study, designed to assess safety and efficacy of the delivery system in percutaneous, trancatheter closure of ostium secundum atrial septal defect (ASD).
The device, which is comprised of a five-wire support frame, features a thin, conformable membrane patch-like EPTFE material, designed to improve closure performance and provide an open microstructure for controlled tissue ingrowth.
The multicentre, prospective, single-arm study is designed to compare the Septal Occluder to outcomes from previous GORE HELEX Septal Occluder clinical studies.
In addition, the study will collect six months post-procedure patient data and will continue to monitor 50 patients at 11 investigational sites for three years, according to the company.
Congenital Heart Centre chief John Rhodes said the first procedure using the GORE Septal Occluder was successful and the patient is doing well.
"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," Rhodes said.
Gore medical division stroke cardiac business spokesperson Stuart Broyles said; "The GORE Septal Occluder Clinical Study for the indication of ASD closure moves us one step closer to bringing this innovative device to the physicians and improving patient outcomes."
In addition to ASD, the Septal Occluder is CE marked for the indication of patent foramen ovale.
Image: GORE Septal Occluder improves closure performance and provides an open microstructure for controlled tissue ingrowth. Photo: Courtesy of Business Wire.