InspireMD, Inc. announced on October 7, 2024, that the U.S. Food and Drug Administration (FDA) approved its Investigational Device Exemption (IDE) Application. This approval allows the company to initiate the CGUARDIANS II pivotal study for its CGuard Prime 80cm Carotid Stent System.
The CGUARDIANS II study will evaluate the CGuard Prime system for use during transcarotid revascularization (TCAR) procedures. This is a significant step towards expanding the application of CGuard Prime into the TCAR market, which currently sees approximately 30,000 procedures performed annually in the U.S.
The study aims to facilitate approval for CGuard Prime in an optimized TCAR version and indication, broadening InspireMD's ability to serve a wider range of physician and patient needs. This initiative is part of the company's strategy to achieve market leadership in the United States.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.