Phase 2 of Neovasc's TIARA-II Study to Commence in Germany and the United Kingdom
January 29, 2019—Neovasc Inc. announced that it has completed the phase 1 requirements of the TIARA-II study required by the biphasic study design in both Germany and the United Kingdom. The company has received approval to proceed with phase 2 of the TIARA-II study for its Tiara transcatheter mitral valve replacement device. The approval will allow the TIARA-II study to proceed in these geographies with no restrictions.
According to the company, this approval comes after adjudication of adverse events by the Clinical Events Committee as well as Data and Safety Monitoring Board review of the data, and governmental regulatory and ethics committee reviews of the interim clinical report provided for 20 patients receiving implants.
The TIARA-II study is an international, multicenter, single-arm, prospective, nonrandomized, safety and performance clinical study. The total enrollment goal for the study in all geographies is 115 implanted subjects.
Tiara is a self-expanding mitral bioprosthesis designed to treat mitral valve regurgitation by replacing the diseased valve. The Tiara valve is currently being evaluated in the TIARA I early feasibility trial in the United States, Canada, and Belgium, and in the TIARA II European CE Mark trial in Germany, Italy, and the United Kingdom.