FDAnews Device Daily Bulletin

Neovasc Completes First Successful Implant of Tiara Transcatheter Mitral Valve

Feb. 5, 2014

Physicians at St. Paul’s Hospital in Vancouver, B.C., performed the first successful human implantation of Neovasc’s Tiara transcatheter mitral valve without incidence of paravalvular leak or residual mitral regurgitation, the Canadian devicemaker said Monday.

The bioprosthetic valve is designed to address challenges such as the native “D” shape of the mitral valve and its large size and high closing pressures, Neovasc said.

Tiara is implanted through the apex of the heart using a catheter to replace the diseased valve while leaving surrounding cardiac structures untouched, according to the company. Implantation takes five to 10 minutes and eliminates the need for open heart surgery or bypass — a needed alternative for patients at high risk with those procedures, said Alan Cheung, a member of the implantation team.

Neovasc is working on validating Tiara and plans to initiate a first-in-man clinical study later this year at centers in Canada, Israel and Belgium, Neovasc CEO Alexei Marko told Device Daily Bulletin. A CE Mark study would likely follow next year, he said.

The company also hopes to conduct a U.S. study under the FDA’s early feasibility guidelines in the near future, Marko said. — Lena Freund

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