A team of cardiologists from the Montreal Heart Institute (MHI) have recently started enrolling patients for the Neovasc ReducerTM, designed to treat patients with refractory angina. This innovative treatment method, the first to be carried out in North America and part of an international study (COSIRA trial), shows promise for scores of Canadian patients disabled by refractory angina and who do not have alternatives for alleviating their signs and symptoms symptoms and improving their quality of life.
The Reducer, which was developed in Canada by Neovasc Inc. (TSX Venture: NVC), is implanted in the patient’s coronary sinus vein using minimally invasive techniques. The device is implanted in a similar way to the placing of a coronary stent – the whole procedure takes no more than about 20 minutes. It 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-François 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 Université de Montréal. “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.
Source: Julie Chevrette
Montreal Heart Institute