11:38 AM EST - Neovasc Inc. : announced that it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate the U.S. arm of its TIARA-I Early Feasibility Trial for the Company's Tiara™ transcatheter mitral valve. The TIARA-I Early Feasibility Trial is a multinational, multi-centre trial being conducted to assess the safety and performance of Neovasc's Tiara mitral valve system and implantation procedure in high-risk surgical patients suffering from severe mitral regurgitation. Neovasc Inc.
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