Neovasc Inc. has received conditional Investigational Device Exemption (IDE) approval from the U.S. 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, multicenter 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 (MR).
