--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 /CNW/ - Neovasc Inc. (TSXV: NVC)
today announced that a review of results from preclinical studies
of its Tiara™ 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 yesterday at the 25th Annual Transcatheter
Cardiovascular Therapeutics (TCT) scientific symposium being held
October 27- November 1, 2013, in
San Francisco, California.
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.