Longer-Term Animal Data Suggests Tiara Device for the Transcatheter Treatment of Mitral Valve Disease Appears Safe and Well Tolerated— 

Paris, France, and Vancouver, BC, Canada – Neovasc Inc., a developer of novel technologies to treat vascular disease, reported that positive animal data from its Tiara^TM program for the transcatheter treatment of mitral valve disease was presented today at EuroPCR 2013, the annual meeting of the European Association for Percutaneous Cardiovascular Interventions.  

Neovasc Medical Director, Professor Shmuel Banai, MD, who is also an Associate Professor of Medicine and Cardiology at Tel Aviv University’s Sackler School of Medicine and Director of Interventional Cardiology at Tel Aviv Medical Center, presented data 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.

Professor Banai commented, “We are encouraged by these results showing that the Tiara mitral valve replacement device was well tolerated for the full 150 days of this study.  Transcatheter mitral valve replacement involves many technical challenges, but a growing body of animal data suggests that the Tiara device is safe and performs very well after implantation.  We look forward to the opportunity to test the Tiara device in human subjects starting later this year or early in 2014.”

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.  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 four million patients in the US alone are estimated to have MR.

Neovasc CEO Alexei Marko commented, “We are making excellent progress in the development of our Tiara technology for the transcatheter treatment of mitral valve disease, and we are pleased to share our promising longer-term animal results with leading interventional cardiologists at EuroPCR.  If our preclinical work continues to go well, we hope to achieve the first implantations in humans in late 2013 or early 2014.” 

Neovasc’s Tiara technology is featured in four scientific sessions at EuroPCR 2013.

Source: Neovasc Inc.