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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
InspireMD (Nasdaq: NSPR) has received FDA approval for its Investigational Device Exemption (IDE) Application to initiate the CGUARDIANS II pivotal studyof the CGuard Prime 80cm Carotid Stent System for transcarotid revascularization (TCAR) procedures. This approval marks a significant milestone in the company's mission to provide comprehensive tools for carotid stent procedures.
The study aims to facilitate approval for using CGuard Prime in an optimized TCAR version and indication. InspireMD is also developing the SwitchGuard NPS, a next-generation TCAR Neuroprotection System. These initiatives are part of the company's strategy to enter the U.S. market and achieve global success in stroke prevention and carotid disease management.
Dr. Patrick Geraghty and Dr. Patrick Muck have been appointed as co-principal investigators for the CGUARDIANS II study.
The study aims to facilitate approval for using CGuard Prime in an optimized TCAR version and indication. InspireMD is also developing the SwitchGuard NPS, a next-generation TCAR Neuroprotection System. These initiatives are part of the company's strategy to enter the U.S. market and achieve global success in stroke prevention and carotid disease management.
Dr. Patrick Geraghty and Dr. Patrick Muck have been appointed as co-principal investigators for the CGUARDIANS II study.
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