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 file for CE Mark approval for Tiara™, indicating the product conforms to the European safety and performance requirements.
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About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Neovasc Reducer™, for the treatment of refractory angina which is not currently available in the U.S. and has been available in Europe since 2015 and the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under investigation in the US, Canada and Europe. The Company also sells a line of advanced biological tissue products that are used as key components in third-party medical products including transcatheter heart valves. For more information, visit the company’s website at www.neovasc.com
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