Neovasc’s Tiara Transcatheter Mitral Valve Shows Positive Animal Data

Longer-term animal data suggests Tiara device appears safe and well-tolerated.


May 24, 2013

May 24, 2013 — Neovasc Inc. reported positive animal data from its Tiara program for the transcatheter treatment of mitral valve disease. Data presented is on long-term implantation of the Tiara mitral replacement valve in an animal model of mitral regurgitation (MR). 

The data shows that all seven animals implanted with the Tiara device were thriving at the end of the 150-day study, with no signs of inflammation or other adverse reactions to the implanted valve.  The Tiara device was well-incorporated into the native anatomy and anchored in place with no evidence of migration.  At 150 days, valve leaflets were functioning well with no significant degradation in hydrodynamic performance or calcification.  In all of the animals, left ventricular outflow was unimpeded, and the aortic valve continued to function normally.

The Tiara program is a novel solution to treat mitral valve regurgitation, a serious and poorly served condition that requires development of highly specialized devices to address the complex mitral anatomy, according to Neovasc.  Mitral regurgitation is often severe and can lead to heart failure and death, but conventional surgical treatments are only appropriate for a small percentage of patients. Approximately 4 million patients in the United States alone are estimated to have MR.

 “If our preclinical work continues to go well, we hope to achieve the first implantations in humans in late 2013 or early 2014,” said Alexei Marko, Neovasc CEO.

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