InspireMD's CGuard Prime Stent Evaluated in CGUARDIANS II TCAR Trial
核心洞察
InspireMD partners with NAMSA (搜索) to conduct the CGUARDIANS II pivotal study, evaluating the CGuard Prime (搜索) 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 (搜索) when used with an FDA-cleared TCAR neuro-protection system.
InspireMD, Inc. is collaborating with NAMSA (搜索), 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 (搜索) 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 (搜索) 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 (搜索)’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 (搜索) 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 (搜索) 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 (搜索) 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 (搜索)-free outcomes.