InspireMD (Nasdaq:NSPR) announced today that the FDA granted investigational device exemption (IDE) for its CGuard Prime 80cm carotid stent system.
The FDA says the company can begin the CGUARDIANS II pivotal study of the system used during transcarotid revascularization (TCAR) procedures. InspireMD picked Dr. Patrick Geraghty and Dr. Patrick Muck to serve as lead investigators for the trial. Geraghty serves as professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis. Muck serves as program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati.
InspireMD submitted the CGuard system for FDA premarket approval last month for the treatment of carotid artery stenosis (CAS). CEO Marvin Slosman said in a news release that the new study aims to broaden the range of the system to TCAR procedures. He said the company hopes the study facilitates approval of the stent in an optimized TCAR version and indication.
The CGuard embolic prevention stent (EPS) system — designed to prevent stroke — received CE mark earlier this year. It utilizes the company’s MicroNet technology for strong acute results and durable, stroke-free, long-term outcomes. In parallel, Slosman said the company continues developing a next-generation TCAR neuroprotection system.
“Each of these initiatives helps pave the way, once approved, for us to initiate commercial sales and strive for market leadership in the U.S.,” said Slosman. Our mission to improve stroke prevention and carotid disease management with our CGuard platforms continues as we build our company toward U.S. expansion and global success.”
