W. L. Gore & Associates has enrolled a first patient in its GORE® Carotid Stent Clinical Study. Tagged SCAFFOLD, The study will compare Gore’s device with traditional carotid endarterectomy data.
Gore has more than 35 years of clinical experience with expanded polytetrafluoroethylene (ePTFE) in the vascular device arena. The company describes its Carotid Stent as a next-generation device designed to integrate innovative material to trap arterial plaque against the vessel wall, while yielding maximized flexibility of the stent in order to conform to the often tortuous anatomy of carotid vasculature.
The SCAFFOLD Clinical Study is a multicenter, single-arm, prospective study comparing the GORE Carotid Stent to a performance goal developed from carotid endarterectomy (CEA) outcomes. The investigational study will include up to 50 sites in the US and will enroll approximately 312 patients. Co-principal investigators are Peter Schneider, MD, Kaiser Permanente Medical Center, Honolulu; and William Gray, MD, Columbia University Medical Center.
The new Gore device combines the flexible properties of a traditional open-cell, nitinol stent design with a 500 micron pore size ePTFE lattice which offers the plaque retention and stabilization benefits traditionally seen in a closed cell stent design. Additionally, the permanently bound heparin may offer a local advantage seen with other Gore devices that utilize bound heparin.
The first patient was successfully treated by Claudio Schönholz, MD, and his team at the Medical University of South Carolina in Charleston.
“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,” Dr. Schönholz said. “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,” said Ben Beckstead, PhD, associate with the Gore Medical Division Peripheral Interventional Business. “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.”
Source: W.L. Gore & Associates, Business Wire