InspireMD Commences CGUARDIANS II Pivotal Study of CGuard Prime Carotid Stent System in TCAR

December 9, 2024—InspireMD, Inc. announced that the first patient has been enrolled in the company’s CGUARDIANS II clinical trial evaluating its CGuard Prime carotid stent system in patients undergoing carotid artery stenting via the transcarotid artery revascularization (TCAR) approach. The device features InspireMD’s MicroNet neuroprotective technology.

InspireMD advised that the study’s first patient was enrolled by Patrick Muck, MD, at Good Samaritan Hospital, part of the TriHealth System in Cincinnati, Ohio, where Dr. Muck is Program Director and Chief of Vascular Surgery.

According to the company, CGUARDIANS II is a prospective, multicenter, single-arm pivotal study that aims to enroll a minimum of 50 evaluable patients. The objective of the study is to evaluate acute device success and technical success of the CGuard Prime when used in conjunction with an FDA-cleared TCAR neuroprotection system in patients at high risk for adverse events from carotid endarterectomy.

In September 2024, InspireMD announced that it had submitted a premarket approval (PMA) application to the FDA seeking marketing approval for the CGuard Prime carotid stent system in the United States. The PMA application is based on 1-year data from the C-GUARDIANS pivotal clinical trial that were presented at LINC 2024, the Leipzig Interventional Course held May 28-31 in Leipzig, Germany.

On October 7, the company announced that the FDA approved its application for an investigational device exemption to initiate the CGUARDIANS II pivotal study of the 80-cm CGuard Prime carotid stent system.

Dr. Muck serves as both Site Principal Investigator at Good Samaritan and colead investigator of the CGUARDIANS II study.

“As we begin this study of CGuard Prime in a TCAR setting, we value tremendously the prior data from the C-GUARDIANS PMA, the real-world results of this implant, and its potential to advance patient care through these unmatched clinical results,” commented Dr. Muck in the company’s press release. “The protective qualities of the MicroNet mesh offer patients the sustainable protection, which is so important in both short- and long-term outcomes of this procedure. We look forward to the efficient enrollment of this study, contribution from the team of investigators, and working with InspireMD on this important program.”