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Neovasc Inc. (TSXV: NVC) has announced that a review of results from preclinical studies of its TiaraTM valve for the transcatheter treatment of mitral regurgitation has been published in JACC: Cardiovascular Interventions. The review concludes that implantation of the Tiara valve is technically feasible, safe and results in a stable and well-functioning mitral bioprosthesis.
Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR), 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. Conventional surgical treatments are only appropriate for a small percentage of the estimated four million patients in the US alone.
"This publication reports on a series of successful Tiara implantations that position us to proceed to the first-in-human Tiara studies we are targeting for early 2014," noted Alexei Marko, CEO of Neovasc. "Publication of these results in a prestigious journal highlights the potential value of Tiara for the growing number of MR patients who cannot be treated surgically. We believe the unique Tiara design may provide important advantages, and we look forward to proceeding to studies in humans next year."
The preclinical studies included both acute and chronic animal models, as well as human cadavers. Researchers used trans-apical mitral implantation (TAMI), an approach that accesses the mitral valve through the tip (apex) of the left ventricle. Use of TAMI allows the interventional cardiologist easier access to the mitral valve and also avoids potential risks associated with the longer femoral access route.
The study results demonstrate that implantation of the Tiara valve in healthy swine and sheep is feasible and safe. The researchers developed a rapid and straightforward implantation procedure resulting in a stable and well-aligned functional bioprosthesis for up to 150 days of follow-up. All of the animals receiving the Tiara device exhibited normal clinical status and behavior without any signs of heart failure. There was no significant mitral regurgitation observed, and left ventricular function was normal in all subjects. The chronic animal experiments confirmed the durability and functionality of the Tiara device in ongoing use, including continuing leaflet pliability, lack of leaflet calcification and good tissue coverage of the device's metal frame.
Neovasc researchers presented data from these preclinical Tiara studies at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium being held October 27- November 1, 2013, in San Francisco, California.
Trans Apical Mitral Implantation (TAMI) of the Tiara TM Bio-prosthesis: Pre-Clinical Results
Authors: Banai S, Verheye S, Cheung A, Schwartz M, Marko A, Lane R, Jolicoeur EM, Garceau P, Biner S, Tanguay J-F, Edelman ER, White CJ
JACC: Cardiovascular Interventions (2013), doi: 10.1016/j.jcin.2013.10.009
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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