InspireMD Inc. (NASDAQ: NSPR) announced 30-day results from its CGUARDIANS II clinical trial evaluating the CGuard Prime 80cm implant for transcarotid artery revascularization procedures. The company has submitted a premarket approval supplement to the FDA, which is currently under review.

The trial enrolled 50 patients across 11 sites and achieved 100% acute device success with no deaths, strokes, or myocardial infarctions reported within 30 days. The study also showed no stent thrombosis and complete stent patency at 30 days in evaluable subjects.

Dr. Patrick J. Geraghty, professor of surgery and radiology at Washington University School of Medicine and co-lead investigator, said the results suggest the CGuard Prime 80cm stent may deliver safety and efficacy when used with a TCAR approach.

The CGuard Prime Carotid Stent System 80cm remains an investigational device in the United States and is limited to investigational use. InspireMD anticipates potential approval in the second half of 2026.

CEO Marvin Slosman stated the company believes the results represent progress toward accessing the TCAR market, which performs more than 35,000 procedures annually in the United States. The company has also initiated the CGUARDIANS III clinical trial of its SwitchGuard neuroprotection system.

The CGUARDIANS II study evaluated the device when used with the FDA-cleared ENROUTE TCAR neuro-protection system in patients considered at high risk for adverse events from carotid endarterectomy.