Neovasc Inc., a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced that it has completed the Phase 1 requirements of the TIARA-II study required by the bi-phasic study design in both Germany and the UK and has received approval to proceed with Phase 2 of the TIARA-II study for its Tiara™ transcatheter mitral valve replacement device.
This approval comes following Clinical Events Committee adjudication of adverse events, Data and Safety Monitoring Board review of the data, and Governmental regulatory and ethics committees reviews of the interim clinical report provided for 20 implanted subjects. This approval will allow the TIARA-II study to proceed in these geographies with no restrictions.
The TIARA-II study is an international, multicenter, single-arm, prospective, non-randomized, safety and performance clinical study. The total enrollment goal for the study in all geographies is 115 implanted subjects.
“The Neovasc team is excited about the positive news from the governmental healthcare authorities in Germany and the UK, as well as from the independent ethics committees in both countries. After their review of the submitted, detailed results of the first 20 Tiara implants, we received all required approvals to continue this TIARA-II clinical study into the second and final phase of full enrollment, without further restrictions,” commented Fred Colen, Neovasc’s President and Chief Executive Officer.
Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Conventional surgical treatments are only appropriate for about half of MR patients, who number an estimated four million in the U.S. with a similar number of patients affected throughout Europe. Tiara is implanted in the heart using a minimally invasive, transapical transcatheter approach without the need for open-heart surgery or use of a cardiac bypass machine.
The Tiara valve is currently being evaluated in 2 ongoing clinical trials: TIARA-I—an early feasibility trial in the United States, Canada, and Belgium—and TIARA-II—a European Conformité Européenne Mark Trial in Germany, Italy, and the United Kingdom. In addition, patients have also been treated under compassionate programs in Canada, Italy, Germany, Israel, and Switzerland.
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 Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada and Europe.