FDA approves IDE for InspireMD's CGUARDIANS II pivotal study of CGuard Prime 80cm stent system

InspireMD, Inc.

FDA approved IDE application for CGUARDIANS II pivotal study of CGuard Prime 80cm Carotid Stent System during TCAR procedures.
Study intended to facilitate approval of CGuard Prime for TCAR indication; U.S. commercial sales after approval.
Co-principal investigators: Patrick Geraghty, M.D. (Washington Univ.) and Patrick Muck, M.D. (Good Samaritan Hospital).
Company also advancing development of next-generation TCAR neuroprotection system, SwitchGuard NPS.

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