Neovasc, a developer of technologies used to treat vascular disease, has enrolled its first patients in its COSIRA trial designed to assess the clinical efficacy of the Neovasc Reducer product for the treatment of refractory angina.
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, according to the Vancouver, British Columbia-based company. The primary endpoint is efficacy in reducing angina symptoms after six months.
The COSIRA study is being conducted under the supervision of Principal Investigator Stefan Verheye, MD, PhD, at the Antwerp Cardiovascular Institute/Ziekenhuis Netwerk Antwerpen Middelheim in Antwerp, Belgium, who performed the first four cases for the study on the first day of patient enrollment last week.
The Neovasc Reducer is implanted in the coronary sinus vein. Neovasc said it is intended to provide relief of refractory angina symptoms by modulating blood flow in the coronary sinus, and thereby increasing perfusion of oxygenated blood to areas of the heart muscle.