The interventional cardiology team at the Montreal Heart Institute, Canada, recently began patient enrolment for a new device, the Neovasc Reducer, designed to treat patients suffering from refractory angina. The treatment method is being conducted as part of the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) trial.
Developed in Canada by Neovasc 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.
The COSIRA trial is a multicentre, sham-controlled, randomised, double-blinded study of the Neovasc Reducer. It is expected to enrol 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 Centre in The Netherlands. Additional sites are expected to join the trial in the coming months.
This procedure was carried out by the interventional cardiologists: Marc Jolicoeur, Serge Doucet and Jean-Francois Tanguay and the heart surgeon, Raymond Cartier. “All the initial cases have gone very well and we are optimistic that the long term results of the procedure will be favourable” said Jolicoeur who is also assistant professor in the faculty of medicine at the Universite de Montreal. “This new method to treat refractory angina safely provides care for patients who cannot be helped with conventional drug, catheter or surgical therapy.”
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.