Neovasc Receives Approval to Initiate TIARA II CE Mark Study

November 28, 2016—Neovasc Inc. announced it has received both regulatory and ethics committee approval to initiate the TIARA II study in Italy. TIARA 2 will evaluate the safety and performance of the company’s self-expanding Tiara transcatheter mitral valve replacement device, which is composed of the Tiara transcatheter mitral valve with the Tiara transapical delivery system.

TIARA II is a 115-patient, nonrandomized, prospective clinical study. The company expects that the first Italian TIARA II clinical study site will be initiated before the end of the year, with first enrollment anticipated in early 2017. Approvals in additional geographies are expected in the first quarter of 2017. Data from this study are expected to be used to file for European CE Mark approval for Tiara, advised Neovasc.