-Initial Data from Patient Registries Shows the Reducer Significantly
Improves Angina Scores at Six Months Post-Implantation-
TSX Venture Exchange: NVC
PARIS and VANCOUVER, May 21, 2013 /CNW/ - Neovasc Inc. (TSXV: NVC), a developer of novel technologies to treat vascular
disease, today reported initial data from open label patient Registries
that are tracking the progress of refractory angina patients implanted
with the Neovasc ReducerTM, a novel percutaneous device that is CE marked in the European Union
for the treatment of refractory angina. The data were presented at
EuroPCR 2013, the annual meeting of the European Association for
Percutaneous Cardiovascular Interventions.
Neovasc Medical Director Professor Shmuel Banai, who is also 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 six-month follow up data from 15
Registry patients showing that their angina and physical disability
were significantly improved after Reducer implantation. Among other
measures, patients were assessed on the Canadian Cardiovascular Society
(CCS) grading scale, which is widely used to describe and classify the
severity of effort-related angina. Despite the small size of this
sample, the change in CCS scores was highly statistically significant
compared to baseline (p=<.001). Patient subsets who received stress
thallium and echo dobutamine testing also showed significant
improvement with the Neovasc Reducer.
Professor Banai commented, "We consider these results very encouraging.
In these initial Registry patients, quality of life improved as average
angina scores were substantially reduced, signalling a significant
improvement in their ability to engage in daily activities without
limiting chest pain. We also are seeing significant improvements in
stress-related objective imaging measures, as well as trends suggesting
that improvements in treadmill stress testing results will reach
significance as our Registry population continues to grow. Consistent
with other experience to date, the Reducer appears very safe, with no
reports of serious safety issues."
The Neovasc Reducer is a percutaneous device designed to treat patients
who suffer from refractory angina, which occurs when there is an
inadequate supply of blood to the heart muscle. Refractory angina
affects millions of patients worldwide. These patients experience
severe chest pain from even minor physical exertion, and therefore lead
restricted lives. The Reducer provides relief from symptoms by
altering blood flow in the coronary sinus vein and thereby increasing
perfusion of oxygenated blood to certain areas of the heart muscle. The
Reducer is inserted using a percutaneous procedure that is similar to
implanting a stent and takes less than 20 minutes.
Neovasc CEO Alexei Marko noted, "These promising data from Reducer
Registry patients are consistent with previous studies, which showed
that refractory angina patients receiving the Reducer continued to show
improvements in angina-related symptoms three years post-implantation.
We expect definitive data from our COSIRA study in the coming months,
which should enable us to plan for broader commercialization in Europe
and to further assess options for regulatory review and
commercialization in the U.S."
Professor Banai presented "The Coronary Sinus Reducer--a Device Based
Therapy for Refractory Angina: Efficacy and Safety Results from the
Ongoing Open Label Registry," at the Outcome in Contemporary Coronary Intervention session held today at EuroPCR from 12:30 - 2:00pm.
EuroPCR is the official annual meeting of the European Association of
Percutaneous Cardiovascular Interventions. EuroPCR 2013 is being held
in Paris, France May 21-24, 2013. For information, visit www.europcr.com.
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 valve 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.
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