InspireMD, Inc. announced on February 13, 2025, a strategic outsourcing partnership with NAMSA, a MedTech Contract Research Organization. The collaboration focuses on conducting the CGUARDIANS II pivotal study for InspireMD's CGuard Prime 80 cm carotid stent system in Transcarotid Artery Revascularization (TCAR) procedures.
CEO Marvin Slosman highlighted that TCAR is a rapidly growing procedure with over 30,000 procedures performed annually in the U.S., representing a significant expansion of InspireMD's addressable market. Leveraging NAMSA's vascular clinical and regulatory expertise is expected to ensure efficient execution of this important study.
The CGUARDIANS II study, which enrolled its first patient on December 9, 2024, is a prospective, multi-center, single-arm trial. It aims to enroll a minimum of 50 evaluable patients to assess the safety and effectiveness of the CGuard Prime stent platform in TCAR procedures.
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