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September 8, 2020
FDA Approves IDE for CARENET-III Pivotal Trial of InspireMD’s CGuard Carotid Stent System
September 8, 2020—InspireMD, Inc., the Israel-based developer of the CGuard embolic prevention system for the prevention of stroke caused by carotid artery disease, announced FDA approval for the company to proceed with the CARENET-III pivotal study of the CGuard carotid stent system for prevention of stroke in patients in the United States.
The company advised that the CARENET-III study would be composed of 315 patients enrolled at up to 40 institutions in the United States. The company will provide additional details as plans advance.
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