Neovasc Inc. Completes Enrollment in Cosira Trial
NEOVASC INC. COMPLETES ENROLLMENT IN COSIRA TRIAL ASSESSSING EFFICACY OF REDUCERTM PRODUCT FOR TREATMENT OF REFRACTORY ANGINA
—Full Data from COSIRA Trial Expected Around Year’s End—
—Initial Data from Reducer Patient Registries To Be Presented at EuroPCR 2013—
May 13, 2013 - Vancouver, BC, Canada - Neovasc Inc. (TSXV: NVC), today announced the completion of patient enrollment in its COSIRA trial designed to further assess the efficacy and safety of the Neovasc ReducerTM, a novel percutaneous device for the treatment of refractory angina. The COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) trial is a double-blinded, randomized, sham-controlled multicenter trial intended to demonstrate the efficacy of the Reducer in a controlled population of refractory angina patients. It was conducted in the UK, Europe and Canada.
“COSIRA was designed as a rigorous study to provide definitive evidence of the efficacy of the Reducer in improving the quality of life of patients with refractory angina, and we look forward to sharing six-month follow-up data from the trial in a peer-reviewed forum around year’s end,” said Shmuel Banai, MD, Chief Medical Officer of Neovasc. “In addition, we are seeing encouraging initial patient data from our Reducer Registries, which we look forward to reporting at EuroPCR next week.”
Results of a published, prospective three-year pilot clinical study have demonstrated that the Reducer is safe and effective in providing relief of angina symptoms in refractory angina patients. The Reducer has received a CE mark designation in Europe for the treatment of refractory angina.
Neovasc CEO Alexei Marko noted, “Patient outcome data from our Reducer pilot studies and the Registry patients enrolled to date have been very promising. If the COSIRA results are consistent with past data, we can move forward with commercialization plans for this novel product that has the potential to help alleviate painful and debilitating symptoms in millions of angina patients who currently lack effective treatment options.”
The Neovasc Reducer is a percutaneous device designed to treat the millions of patients worldwide who suffer from refractory angina, which occurs when there is an inadequate supply of blood to the heart muscle. Refractory angina currently affects an estimated one million patients in Europe, who often lead severely restricted lives. The incidence of refractory angina is growing, yet treatment options are limited.
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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Posted: May 2013