--Preclinical Studies Show Innovative Transcatheter Product to Treat
Mitral Regurgitation is Safe, Technically Feasible and Results in a
Well-Functioning Mitral Bioprosthesis-
--Sets Stage for First-in-Human Implantations Targeted for Early 2014--
TSX Venture Exchange: NVC
VANCOUVER, Oct. 29, 2013 /PRNewswire/ - Neovasc Inc. (TSXV: NVC) today
announced that a review of results from preclinical studies of its
Tiaravalve 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
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
Neovasc researchers presented data from these preclinical Tiara studies
yesterday at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific
symposium being held October 27- November 1, 2013, in San Francisco,
The article, 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,
Trans Apical Mitral Implantation (TAMI) of the Tiara TM Bio-prosthesis:
Pre-Clinical Results, JACC: Cardiovascular Interventions (2013), doi: 10.1016/,is currently available online at http://jaccinter.cardiosource.com/JCIN2013_Banai.pdf. It will also be published in an upcoming edition of JACC: Cardiovascular Interventions.
About Neovasc Inc.
Neovasc Inc. is a specialty medical device company that develops,
manufactures and markets products for the rapidly growing global
cardiovascular marketplace. Its products include the Neovasc Reducer
for the treatment of refractory angina and the Tiara transcatheter
mitral value replacement device in development for the treatment of
mitral regurgitation. In addition, Neovasc's advanced biological tissue
products are widely used as key components in a variety of third-party
medical products, such as transcatheter heart valves. For more
information, visit: www.neovasc.com.
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SOURCE Neovasc Inc.