W.L. Gore & Associates said it’s launched the Scaffold clinical trial of a stent designed to treat carotid artery stenosis.
The 1st patient in the trial was implanted with the device by Dr. Claudio Schönholz of the Medical University of South Carolina in Charleston, according to a press release.
The stent, which is made of expanded polytetrafluoroethylene, is designed to trap plaque against the arterial wall yet be flexible enough to "to conform to the often tortuous anatomy of carotid vasculature," according to the release.
The 312-patient Scaffold trial is slated to compare the Gore device with carotid endarterectomy at up to 50 U.S. sites.
"The first procedure using the Gore carotid stent was successful and the patient is doing well, having left the hospital the next day. Studies like this will further our understanding of optimal patient outcomes in carotid artery stenosis," Schönholz said in prepared remarks. "The new Gore device is designed to be flexible, offer plaque retention and stabilization benefits, and along with bound heparin may provide advantages for improved patient outcomes."
"Gore is committed to continuing development of innovative solutions for patients in order to improve their quality of life," added Gore Medical Division Peripheral Interventional Business associate Ben Beckstead. "The Gore Scaffold Clinical Study will bring us one step closer to a new solution for improving patient outcomes, while simultaneously generating data for consideration of Medicare reimbursement for such procedures."
