Pivotal Study Begins for InspireMD’s SwitchGuard NPS in TCAR Procedures

June 8, 2026—InspireMD, Inc. announced that the first patient has been enrolled in the CGUARDIANS III pivotal study of its SwitchGuard neuroprotection system (NPS).

According to the company, CGUARDIANS III is a prospective, multicenter, single-arm, pivotal study that will enroll approximately 103 patients. The study’s objective is to evaluate the safety and efficacy of the SwitchGuard NPS in providing cerebral embolic protection during transcarotid artery revascularization (TCAR) procedures with the company’s CGuard Prime 80-cm stent system for the treatment of carotid artery stenosis in patients at high risk for complications from carotid endarterectomy (CEA), noted InspireMD.

The Global Coprincipal Investigators for the CGUARDIANS III trial are Patrick Muck, MD, and Patrick J. Geraghty, MD.

Dr. Muck, who enrolled the first patient in the trial, is from Good Samaritan Hospital, part of the TriHealth System in Cincinnati, Ohio. Dr. Geraghty, professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, Missouri.

In the company’s press release, Dr. Muck commented, “Building on the strong clinical momentum established by the CGUARDIANS II study of CGuard Prime 80 cm with FDA-cleared neuroprotection systems, we are excited to advance into the next phase of innovation with the CGUARDIANS III study of the SwitchGuard NPS.”

Dr. Muck continued, “SwitchGuard represents a natural evolution of InspireMD’s commitment to achieving the best clinical outcomes in carotid artery disease, particularly in the growing adoption of TCAR procedures. By combining the proven performance of CGuard Prime with next-generation neuroprotection, we aim to further enhance procedural safety while reducing stroke risk and providing physicians with a comprehensive solution tailored to the needs of their patients. We believe SwitchGuard, if approved, has the potential to set a new standard of care in carotid revascularization.”