InspireMD has announced the commencement of patient enrollment for its pivotal CGUARDIANS II study. This research will explore the efficacy of the CGuard Prime Carotid Stent System during trans carotid artery revascularization (TCAR) procedures. Dr. Patrick Muck, the co-principal investigator, enrolled the first patient at Good Samaritan Hospital in Cincinnati, Ohio.
CGUARDIANS II aims to measure the success of the CGuard Prime system paired with an FDA-approved TCAR neuroprotection device. The study seeks to recruit at least 50 patients considered at high risk for complications from carotid endarterectomy surgery.
“Approaching the potential FDA nod for CGuard Prime with a CAS indication by the first half of next year is promising,” CEO Marvin Slosman revealed in an SEC filing. “We’re thrilled to have kicked off the CGUARDIANS II study. If successful, it will tap into a growing TCAR market, witnessing approximately 30,000 procedures in the United States this year. A huge thank you to Dr. Muck for achieving this significant enrollment milestone. We are keen on the efficient progression of this crucial study, facilitating the broad application of the CGuard Prime system, offering patients and healthcare professionals this pioneering stenting solution that has yielded unparalleled clinical results and sold over 60,000 units to date.”
Building on data from the C-GUARDIANS PMA study and real-world application of the CGuard platform, the CGUARDIANS II trial could significantly advance InspireMD’s presence in the U.S. TCAR sector.
“As we embark on this investigation of CGuard Prime within a TCAR context,” Muck acknowledged, “the foundational data from the C-GUARDIANS PMA and the real-world impact of this device underscore its potential to enhance patient outcomes with clinical results like no other. The MicroNet mesh offers enduring protection crucial for both immediate and long-term procedural outcomes. We’re eager for the smooth enrollment of this study, contributions from the investigative team, and our collaboration with InspireMD for this pivotal program.”
Earlier, InspireMD secured FDA investigational device exemption (IDE) for the CGuard Prime carotid stent system and achieved CE mark approval, emphasizing its design to prevent strokes with its embolic prevention technology.