On 19 October, Gore reported the first patient enrolled in the US 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). Gore announced that the patient was successfully treated at Duke University Medical Center in Durham, North Carolina, USA, by John Rhodes, chief of the Congenital Heart Center; and Mandy Green.
The US 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 first procedure using the Gore Septal Occluder was successful and the patient is doing well, having left the hospital the next day,” said Rhodes. “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.”
The Gore Septal Occluder received the CE mark in June 2011 for the indication of ASD and patent foramen ovale (PFO).
Gore Septal Occluder
The Gore Septal Occluder 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 Gore Septal Occluder delivery system allows for one hand control. This gives the physician an intuitive, reliable and consistent delivery experience. Enabling precise positioning and repositioning creates optimal occluder placement in even the most challenging anatomies.