February 25, 2011
A North American First At The Montreal Heart Institute Could Help Treat Thousands Of Canadians
Successful initiation of trial for new device designed to treat patients who suffer from refractory angina
The interventional cardiology team at the Montreal Heart Institute (MHI) recently began patient enrolment for a new device, the Neovasc ReducerTM, designed to treat patients suffering from refractory angina. The treatment method is a first in North America and is being conducted as part of an international study, the COSIRA trial. This innovative treatment is promising for thousands of Canadians disabled by refractory angina and who lack alternatives for relieving their symptoms and improving their quality of life.Developed in Canada by Neovasc Inc. (TSX Venture: NVC), the Reducer is implanted in the coronary sinus vein using minimally invasive techniques. Placement of the device is performed using a procedure that is similar to implanting a coronary stent and takes approximately 20 minutes. The Reducer is designed to establish a permanent and controlled narrowing of the coronary sinus, which is a new technique to provide relief of refractory angina symptoms by altering blood flow in the coronary sinus and thereby increasing perfusion of oxygenated blood to certain areas of the heart muscle that receive an inadequate supply of oxygen. Patients are discharged within 24 hours after the intervention.
This landmark procedure was carried out by a MHI multidisciplinary team composed of Drs. Marc Jolicoeur, Serge Doucet and Jean-FranÃ§ois Tanguay, interventional cardiologists, as well as Dr. Raymond Cartier, heart surgeon. "All the initial cases have gone very well and we are optimistic that the long term results of the procedure will be favourable" says Dr. Marc Jolicoeur who is also assistant professor in the faculty of medicine at the Universit© de Montr©al. "This new method to treat refractory angina safely provides care for patients who cannot be helped with conventional drug, catheter or surgical therapy."
The COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) trial is a multicenter, sham-controlled, randomized, double-blinded study of the Reducer that is expected to enroll up to 124 patients. The primary endpoint is efficacy in reducing angina symptoms after six months. In addition to the Montreal Heart Institute, the COSIRA trial is also enrolling patients at the University of Ottawa Heart Institute, the Antwerp Cardiovascular Institute and Ziekenhuis Oost-Linburg Hospital in Belgium; and Ultrecht Medical Center in the Netherlands. Additional sites are expected to join the trial in the coming months.
Results from the initial first-in-man clinical trial of the Reducer were presented at the American College of Cardiology 2010 annual meeting. The data showed that three years after implantation of the Reducer, the product remained safe and the majority of the 15 patients treated continued to show measurable improvement in angina symptoms.
About refractory angina
Refractory angina is a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle. It currently affects over two million patients worldwide, who typically lead severely restricted lives and current treatment options are limited. The incidence of refractory angina is currently growing as better treatments for coronary artery disease reduce mortality and increase number of patients with advanced disease.
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