NAMSA: 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

InspireMD, Inc. and NAMSA announced that, pursuant to a previously announced strategic outsourcing partnership, the companies are working together to conduct the CGUARDIANS II pivotal study of InspireMD?s CGuard Prime? 80 cm carotid stent system for use in Transcarotid Artery Revascularization (TCAR) procedures. On December 9, 2024, InspireMD announced that the first patient had been enrolled into the CGUARDIANS II clinical study. CGUARDIANS II is a prospective, multi-center, single arm pivotal study that aims to enroll a minimum of 50 evaluable patients. The objective of this study is to evaluate acute device success and technical success of the CGuard Prime when used in conjunction with an FDA-cleared TCAR neuro-protection system in patients at high risk for adverse events from carotid endarterectomy. InspireMD, Inc. and NAMSA announced that, pursuant to a previously announced strategic outsourcing partnership, the companies are working together to conduct the CGUARDIANS II pivotal study of InspireMD?s CGuard Prime? 80 cm carotid stent system for use in Transcarotid Artery Revascularization (TCAR) procedures. On December 9, 2024, InspireMD announced that the first patient had been enrolled into the CGUARDIANS II clinical study. CGUARDIANS II is a prospective, multi-center, single arm pivotal study that aims to enroll a minimum of 50 evaluable patients. The objective of this study is to evaluate acute device success and technical success of the CGuard Prime when used in conjunction with an FDA-cleared TCAR neuro-protection system in patients at high risk for adverse events from carotid endarterectomy.