09:55 AM EST - Neovasc Inc. : Has received approval of the U.S. Food and Drug Administration to initiate the COSIRA-II IDE pivotal clinical trial. The trial's purpose will be to demonstrate the safety and effectiveness of the Company's novel Reducer system for treatment of patients with refractory angina. Once completed, the trial data is intended to support an application to the FDA for approval to begin marketing Reducer in the United States. Neovasc Inc.
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