newsfilter
← Latest News
GlobeNewswire·

InspireMD Announces First Patient Enrolled in the CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System for Use in TCAR Procedures

NSPR
  • InspireMD, Inc. announced the enrollment of the first patient in the CGUARDIANS III pivotal study for its SwitchGuard neuroprotection system used with the CGuard Prime 80 cm stent platform in transcarotid artery revascularization procedures.
  • Dr. Patrick Muck at Good Samaritan Hospital in Cincinnati, Ohio, enrolled the initial patient, while Dr. Muck & Dr. Patrick Geraghty serve as global co-principal investigators.
  • The prospective, multi-center, single-arm study plans to enroll approximately 103 subjects to evaluate the safety & efficacy of SwitchGuard for cerebral embolic protection during TCAR procedures.
  • The trial targets patients at high risk for complications from carotid endarterectomy by treating carotid artery stenosis using the CGuard Prime system.
  • CEO Marvin Slosman stated the study aims to advance the TCAR toolkit for an estimated 70,000 annual U.S. procedures by 2030 & enhance stroke prevention outcomes.
  • The study builds on clinical momentum from the CGUARDIANS II trial, which utilized CGuard Prime with FDA-cleared neuroprotection systems.
  • The clinical trial is registered at clinicaltrials.gov under study ID NCT07277296.
  • InspireMD trades on Nasdaq under the ticker symbol NSPR & utilizes proprietary MicroNet mesh technology for its carotid stenting products.
  • The press release includes forward-looking statements regarding market size projections, regulatory approval, & clinical trial results that are subject to various risks & uncertainties.