Findings Published From Initial Cases With Neovasc's Tiara TMVR Device
October 22, 2018—Neovasc Inc. announced the publication of findings from the initial experiences of transcatheter mitral valve replacement (TMVR) using the company's Tiara valve in patients with previous aortic valve replacement. The study was published by Anson Cheung, MD, et al in Circulation: Cardiovascular Interventions.
The company stated that the investigators describe the periprocedural and short-term outcomes of patients with severe mitral regurgitation (MR) and previous surgical aortic valve prosthesis replacement treated with the Tiara device. They report a procedural success rate of 100% with no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. In addition, MR was eliminated in patients immediately after implantation.
The investigators concluded, "Transapical mitral valve replacement with the Tiara valve in high-risk patients with severe MR and aortic valve prostheses is technically feasible and can be performed safely." In an accompanying editorial in Circulation: Cardiovascular Interventions titled, "Taking Transcatheter Mitral Valve Replacement to the Next Level", Mayra Guerrero, MD, and Charanjit Rihal, MD, concluded, "The investigators, are taking the field of TMVR to the next level where both prosthetic aortic valves and transcatheter mitral prosthesis coexist, and should be congratulated for their contribution."
According to Neovasc, Tiara is a self-expanding mitral bioprosthesis for transapical transcatheter implantation in patients with mitral regurgitation. Tiara, which is not currently approved for commercial sale in any geographies, is currently under clinical investigation in the United States, Canada, and Europe.
Tiara is being evaluated in two ongoing investigational clinical trials: TIARA-I, an early feasibility trial in the United States, Canada, and Belgium; and TIARA-II, a European CE Mark trial in Germany, Italy, and the United Kingdom. In addition, patients have also been treated under compassionate use programs in Canada, Italy, Germany, Israel, and Switzerland.