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InspireMD's CGuard Prime Stent Evaluated in CGUARDIANS II TCAR Trial

• InspireMD partners with NAMSA to conduct the CGUARDIANS II pivotal study, evaluating the CGuard Prime 80 cm carotid stent system in TCAR procedures. • The CGUARDIANS II trial is a prospective, multi-center, single-arm study aiming to enroll at least 50 patients at high risk for adverse events from carotid endarterectomy. • The study assesses the acute device and technical success of CGuard Prime when used with an FDA-cleared TCAR neuro-protection system. • First patient enrolled in December 2024, marking progress toward potential FDA approval and expansion into the growing TCAR market.

InspireMD, Inc. is collaborating with NAMSA, a MedTech contract research organization, to conduct the CGUARDIANS II pivotal study. This trial will assess the safety and efficacy of InspireMD’s CGuard Prime 80 cm carotid stent system when used during Transcarotid Artery Revascularization (TCAR) procedures.
The CGUARDIANS II study is designed as a prospective, multi-center, single-arm pivotal trial. It aims to enroll a minimum of 50 patients who are considered at high risk for adverse events typically associated with carotid endarterectomy. The primary objective is to evaluate the acute device success and technical success of the CGuard Prime stent when used in conjunction with a neuroprotection system cleared by the FDA for TCAR procedures. The first patient was enrolled in the study on December 9, 2024.

Strategic Importance of TCAR

TCAR is a rapidly expanding method, with over 30,000 procedures performed annually in the U.S. "TCAR represents a significant potential expansion of our addressable market," said Marvin Slosman, CEO of InspireMD, "and the lynchpin of our effort to serve the broadest patient population by supporting both CAS and TCAR carotid stenting procedures."

Expert Perspectives

Dr. Adam Saltman, NAMSA’s Chief Medical Officer, highlighted the study's design, stating, "The CGUARDIANS II study is a well-designed pivotal study that will evaluate the safety and effectiveness of the TCAR procedure as performed with the novel CGuard Prime stent platform with an FDA-authorized embolic protection device."
Dr. Patrick Muck, the site principal investigator at Good Samaritan Hospital in Cincinnati, emphasized the potential of the CGuard Prime Carotid Stent System to enhance patient care through superior clinical results. "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," Muck stated.

CGuard Prime Stent System

The CGuard Prime Carotid Stent System utilizes InspireMD's MicroNet technology. The company aims to establish its products as the standard for carotid stenting, delivering strong acute results and lasting, stroke-free outcomes.
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Reference News

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InspireMD and NAMSA to Partner on CGUARDIANS II Pivotal Clinical Trial of the CGuard Prime™ 80 cm Carotid Stent System for Use in TCAR procedures
markets.businessinsider.com · Feb 13, 2025
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InspireMD and NAMSA to partner on CGUARDIANS II pivotal clinical trial - NeuroNews
neuronewsinternational.com · Feb 13, 2025
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InspireMD Announces First Patient Enrolled in CGUARDIANS II Pivotal Study
etfdailynews.com · Dec 11, 2024

InspireMD, Inc. announced the first patient enrollment in its CGUARDIANS II clinical trial, evaluating the CGuard Prime ...

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First patient enrolled in InspireMD's CGUARDIANS II pivotal study - Vascular News
vascularnews.com · Dec 9, 2024

InspireMD initiates CGUARDIANS II trial, enrolling its first patient at Good Samaritan Hospital for evaluating CGuard Pr...

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