W. L. Gore & Associates has reported the first patient enrolled in the Gore® Septal Occluder Clinical Study evaluating the safety and efficacy of the new Gore Septal Occluder in the treatment of percutaneous, trancatheter closure of ostium secundum atrial septal defect (ASD).
The Gore device is comprised of a five-wire support frame covered with a thin ePTFE, patch-like material. The soft, strong and conformable membrane is intended to improve closure performance, providing an open microstructure to encourage fast, controlled tissue ingrowth.
The company says its Septal Occluder is a next generation device that successfully integrates innovative material and design to yield a treatment option whose discs are intended to conform to the anatomy of the individual patient.
One-hand control gives the physician an intuitive, reliable and consistent delivery experience. Gore says that by enabling precise positioning and repositioning, occluder placement can be optimised in even the most challenging anatomies.
The U.S. prospective, multicentre, single-arm, clinical study will compare the Gore Septal Occluder to outcomes from previous Gore® Helex® Septal Occluder clinical studies. The Gore Study will collect patient data six months post-procedure and will continue to monitor patients for three years from 50 patients at 11 investigational sites.
The patient was successfully treated at Duke University Medical Center in Durham, North Carolina by John Rhodes, MD, Chief of the Congenital Heart Center; and Mandy Green, FNP-C. Dr Rhodes commented “The first procedure using the GORE Septal Occluder was successful and the patient is doing well, having left the hospital the next day. 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. It is critical for physicians to help complete studies like this in an effort to get new and novel technologies into the hands of doctors to aid patient needs.”
“Gore is committed to bringing patients viable and beneficial treatment options that improve their quality of life,” said Stuart Broyles, PhD, Associate with the Gore Medical Division Stroke Cardiac Business. “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.”
The Gore Septal Occluder received CE Mark approval in June 2011 for the indication of ASD and patent foramen ovale (PFO). Globally, more than 1,500 devices have been implanted successfully.