NetworkNewsBreaks – Neovasc, Inc. (NVCN) Receives Regulatory Approval for TIARA II CE Mark Study
Neovasc (NASDAQ: NVCN) (TSX: NVC) says it has received both regulatory and ethics committee approval to initiate the Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA II) in Italy. TIARA II is a 115-patient prospective clinical study evaluating the safety and performance of the Tiara™ Transcatheter Mitral Valve with the Tiara™ Transapical Delivery System (Tiara™). Following this approval, the first Italian TIARA II clinical study will begin before year end and the first enrollment early in the New Year. Approvals in additional geographies are expected in the first quarter of 2017. Data from this study is anticipated to be used to…







