FDA Approves InspireMD’s CGuard Prime Transcarotid Stent System for TCAR

November 12, 2026—InspireMD, Inc. announced that the FDA has approved the company’s premarket approval (PMA) supplement for the CGuard Prime transcarotid stent system for use in transcarotid artery revascularization (TCAR) procedures. The device features an 80-cm delivery system for TCAR procedures when used in conjunction with an embolic protection system specified in the labeling.

According to the company, the approval gives physicians performing TCAR access to the CGuard Prime stent and the company’s MicroNet technology, a permanent protective micromesh that covers the self-expanding nitinol stent.

InspireMD advised that approval of the CGuard Prime transcarotid stent system is supported by data from the company’s CGUARDIANS II pivotal trial, a prospective, multicenter, single-arm United States study that enrolled 50 patients across 11 investigational sites. The study evaluated the CGuard Prime transcarotid stent system platform with TCAR using the FDA-cleared Enroute transcarotid neuroprotection system (NPS; Boston Scientific Corporation) in a high-surgical-risk population.

The company reported that at 30 days, the study achieved 100% acute device success, with no deaths, strokes, myocardial infarctions, or stent thrombosis reported and complete stent patency observed in evaluable patients.

The availability of the CGuard Prime transcarotid stent system with an existing FDA-cleared NPS allows InspireMD to enter the TCAR market independently of the company’s ongoing development of its SwitchGuard NPS, which is an investigational device and is not available for sale in the United States, noted the company.

Patrick J. Geraghty, MD, Professor of Surgery and Radiology at Washington University School of Medicine in St. Louis, Missouri, serves as Co-Lead Investigator of the CGUARDIANS II study.

“TCAR has become an increasingly important technique for carotid revascularization in the United States, and we believe the availability of CGuard Prime for TCAR gives physicians a differentiated stent option designed around sustained embolic protection,” commented Dr. Geraghty in the InspireMD press release. “The ability to combine CGuard’s MicroNet technology with transcarotid access and existing flow-reversal neuroprotection provides physicians with an important new option for treating patients with carotid artery disease.”