TEL AVIV, Israel, Sept. 08, 2020 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE:NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced the U.S. Food and Drug Administration ("FDA" or "the Agency") has granted approval for the company to proceed with a pivotal study of the CGuard™ Carotid Stent System, CARENET-III, for prevention of stroke in patients in the United States.
"This is a key milestone in the history of our company as it helps pave the way for us to initiate a clinical trial of CGuard EPS for addressing Carotid Artery Disease and preventing stroke in the United States market. This will be the first U.S.-based study of CGuard which is a cornerstone of our global expansion plans," said Marvin Slosman, InspireMD's CEO. "A pivotal trial of this kind requires significant preparation and allocation of resources and we have already begun to move pieces into place in order to plan the initiation of our CARENET-III study. The FDA approval of the IDE represents an important step in enabling us to conduct a pivotal clinical trial to demonstrate the potential for CGuard EPS against carotid artery disease, which accounts for more than 6.2 million deaths worldwide, and a cost burden of more than $34 billion in the U.S. alone."
The CARENET-III study would be a 315-subject study with up to 40 U.S. institutions. The company will provide additional details as plans advance.