InspireMD has announced US Food and Drug Administration (FDA) approval of the company’s investigational device exemption (IDE) application to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm carotid stent system during transcarotid artery revascularisation (TCAR) procedures.
In February 2024, InspireMD also announced that professor of surgery and radiology Patrick Geraghty (Washington University School of Medicine, St Louis, USA), and programme director and chief of vascular surgery Patrick Muck (Good Samaritan Hospital, Cincinnati, USA), had agreed to act as lead investigators for the trial.
Marvin Slosman, chief executive officer of InspireMD, stated: “The approval of our CGUARDIANS II IDE is an important milestone and a significant step forward in our mission to serve the broadest range of physician and patient needs with a comprehensive set of tools that can deliver our best-in-class carotid stent system, CGuard Prime, for both carotid artery stenting and TCAR procedures. The CGUARDIANS II study is intended to facilitate approval of the use of CGuard Prime in an optimised TCAR version and indication.
“In parallel, we continue to advance development of our comprehensive, next-generation TCAR neuroprotection system, SwitchGuard NPS. Each of these initiatives helps pave the way, once approved, for us to initiate commercial sales and strive for market leadership in the USA. Our mission to improve stroke prevention and carotid disease management with our CGuard platforms continues as we build our company toward US expansion and global success. Additionally, as we previously announced, we are thrilled to have Geraghty and Muck as co-principal investigators for the study, as well as a world-class group of investigators committed to the trial’s success.”
