InspireMD Announces Approval of Investigational Device Exemption (IDE) Application for CGUARDIANS II Pivotal Study of the CGuard Prime 80cm Carotid Stent System

Core Points - InspireMD, Inc. has received FDA approval for its Investigational Device Exemption (IDE) Application to start the CGUARDIANS II pivotal study for the CGuard Prime 80cm Carotid Stent System during transcarotid revascularization (TCAR) procedures [1] - The company aims to enhance stroke prevention and carotid disease management through its CGuard platforms, with a focus on expanding its market presence in the U.S. and globally [3] - The CGUARDIANS II study is expected to facilitate the approval of the CGuard Prime for optimized TCAR procedures [3] Company Overview - InspireMD utilizes its proprietary MicroNet® technology to establish its products as the industry standard for carotid stenting, aiming for superior acute results and long-term stroke-free outcomes [4] - The common stock of InspireMD is traded on Nasdaq under the ticker symbol NSPR [4] Key Personnel - Dr. Patrick Geraghty and Dr. Patrick Muck have been appointed as lead investigators for the CGUARDIANS II trial, bringing significant expertise to the study [2][3]