Neovasc receives regulatory approval to initiate TIARA II CE Mark study
Neovasc announced it has received both regulatory and ethics committee approval to initiate the Tiara Transcatheter Mitral Valve Replacement Study in Italy. TIARA II is a 115 patient, non-randomized, prospective clinical study evaluating the safety and performance of the Tiara Transcatheter Mitral Valve with the Tiara Transapical Delivery System. With these critical approvals now in place, it is expected that the first Italian TIARA II clinical study site will be initiated before year end, with first enrollment anticipated early in the new year. Approvals in additional geographies are expected in the first quarter of 2017. It is expected that data from this study will be used to file for CE Mark approval for Tiara. CE Mark is the European Union regulatory approval to commercialize a medical device. Receiving the CE Mark demonstrates that a product has been assessed by the EU authorities and conforms to the European essential requirements for safety and performance.