InspireMD Inc. (NASDAQ: NSPR) announced that the first patient has been enrolled in its CGUARDIANS III pivotal study of the SwitchGuard neuro protection system for use in transcarotid artery revascularization procedures. The patient was enrolled by Dr. Patrick Muck at Good Samaritan Hospital in Cincinnati, Ohio.

The study will evaluate the safety and efficacy of the SwitchGuard neuro protection system combined with InspireMD's CGuard Prime 80 cm stent platform for treating carotid artery stenosis in patients at high risk for complications from carotid endarterectomy.

Dr. Muck and Dr. Patrick Geraghty from Washington University School of Medicine in St. Louis will serve as global co-principal investigators for the trial. CGUARDIANS III is designed as a prospective, multi-center, single-arm study that will enroll approximately 103 subjects.

The company stated that the study builds on clinical data from the CGUARDIANS II study of CGuard Prime 80 cm with FDA-cleared neuro protection systems. InspireMD develops carotid stent systems using its proprietary MicroNet mesh technology.

The Miami-based company estimates that 70,000 TCAR procedures will be performed annually in the U.S. by 2030, according to information provided in the press release.