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InspireMD Announces Approval of Investigational Device Exemption (IDE) Application for CGUARDIANS II Pivotal Study of the CGuard Prime 80cm Carotid Stent System
MIAMI, Oct. 07, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of
About this update from Inspiremd Inc.
[{"type":"text","content":"MIAMI, Oct. 07, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has approved 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 revascularization (TCAR) procedures. In February 2024, InspireMD announced that Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, have 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 CAS and TCAR procedures. The CGUARDIANS II study is intended to facilitate approval of the use of CGuard Prime in an optimized 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 United States. Our mission to improve stroke prevention and carotid disease management with our CGuard platforms continues as we build our company toward U.S. expansion and global success. Additionally, as we previously announced, we are thrilled to have Dr. Patrick Geraghty and Dr. Patrick Muck as co-principal investigators for the study, as well as a world class group of investigators committed to the trial’s success,” Mr. Slosman concluded. About InspireMD, Inc.InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR. We routinely pos...