TSX Venture Exchange: NVC
--Three-year Follow-Up Study on Patients Implanted with the Neovasc
Reducer Shows Continued Excellent Safety Profile and Encouraging Signs of
VANCOUVER, May 14 /CNW/ - Neovasc Inc. (TSXV: NVC), a developer of novel
technologies used to treat vascular disease, today announced top-line positive
preliminary results from the follow-up phase of a clinical trial of its
Neovasc Reducer(TM) for the treatment of refractory angina. The data shows
that after three years, the majority of patients implanted with the Reducer
device continue to show measurable improvement in angina symptoms and safety
continues to be excellent. These preliminary results update positive six-month
data previously reported in the Journal of the American College of
Refractory angina is a painful and debilitating condition that results
from lack of adequate blood flow through the coronary arteries that feed the
heart. It currently affects over two million patients worldwide who typically
lead severely restricted lives, and its incidence is growing. The Neovasc
Reducer is a unique device that is implanted in the coronary sinus vein. By
altering the pattern of blood flow perfusing the heart, the Reducer is
intended to provide relief of refractory angina symptoms. Implantation of the
Reducer is performed using a minimally invasive percutaneous procedure that is
similar to implanting a coronary stent and takes approximately 20 minutes.
"The preliminary results from this three-year follow-up confirm the
positive data seen in the initial study and are very promising," said Dr.
Shmuel Banai, principal investigator of the study and medical director of
Neovasc. "We are encouraged by the continuing excellent safety profile of the
Reducer and its apparent ability to maintain improvement in angina symptoms
over time. This data suggests that the Reducer may offer a viable long-term
treatment option for refractory angina patients who have failed other
therapies. We look forward to sharing the full results from this study in a
peer-reviewed scientific forum in the coming months."
In the trial, 15 patients with refractory angina were implanted with the
Reducer device. One patient was subsequently excluded from the original
six-month efficacy analysis due to an unrelated condition. All 14 of the
remaining patients have continued in follow-up for three years or more.
Preliminary results of the three-year follow-up showed that there were no
device-related adverse events or complications reported in these patients,
confirming the excellent safety profile observed in the initial six-month
follow-up period. Treatment with the Reducer also appears to be durable -
after three or more years, the majority of the 14 patients continued to
maintain an improvement in angina symptoms.
"While these results are still preliminary, they support our expectations
that the Reducer could greatly benefit patients suffering from refractory
angina and allow them to resume a more active lifestyle," said Neovasc CEO,
Alexei Marko. "We look forward to completing final analysis of the data from
this study and continuing to advance Reducer through the clinical and
regulatory review process."
(1) Banai S, Ben Muvhar S, Parikh KH, et. al. Coronary Sinus Reducer
Stent for the Treatment of Chronic Refractory Angina Pectoris.
J Am Coll Cardiol 2007;49: 1783-9
About Neovasc Inc.
Neovasc Inc. is a new specialty vascular device company that develops,
manufactures and markets medical devices for the rapidly growing vascular and
surgical marketplace. The company's current products include the Neovasc
Reducer(TM), a novel product in development to treat refractory angina, as
well as a line of advanced biological tissue technologies that are used to
enhance surgical outcomes and as key components in a variety of third party
medical products. For more information, visit: www.neovasc.com.
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"anticipates," "believes," "may," "continues," "estimates," "expects," and
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For further information:
For further information: Corporate contact: Neovasc Inc., Chris Clark,
(604) 248-4138; U.S. media & investor contact: GendeLLindheim BioCom Partners,
Barbara Lindheim, (212) 918-4650