InspireMD receives IDE approval from FDA for CGUARDIANS II pivotal trial

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InspireMD has announced that the 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 revascularization (TCAR) procedures.

In February 2024, InspireMD announced that professor of surgery and radiology Patrick Geraghty, MD, from Washington University School of Medicine in St. Louis, and program director and chief of vascular surgery Patrick Muck, MD, from Good Samaritan Hospital in Cincinnati, Ohio, have agreed to act as lead investigators for the trial.

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