Neovasc Inc. announced the publication of a case series in the journal Cardiovascular Revascularization Medicine describing successful uses of the Neovasc Reducer™ (“Reducer”) under a compassionate use protocol in the United States. The patients were treated under the care of Ryan Gindi, M.D., and the procedures were performed by Gerald Koenig, M.D., Ph.D, both from the Division of Cardiology, Henry Ford Hospital, Detroit. Following the commencement of the COSIRA-II Trial in the United States, qualifying patients are now eligible to be treated in a clinical trial for the device.

The first patient treated with the Reducer is a 59-year-old male with diabetes suffering from severe coronary artery disease and debilitating refractory angina. The patient had a history of multiple stenting procedures, radiation therapy to treat blocked stents, and extensive medications to treat his chest pain. Despite all efforts to alleviate his anginal symptoms, he lived a significantly restricted lifestyle because of his chest pain.

After implantation of the Reducer device, the patient became largely asymptomatic and did not require any further interventional therapy. He described walking several miles around Washington, D.C. without angina. The second patient is another 59-year-old male with an extensive history of coronary artery disease who previously suffered multiple heart attacks, underwent coronary artery bypass surgery and had multiple stenting procedures to control his symptoms. Despite all efforts and extensive medications, he remained severely restricted by his angina, and was subsequently treated with the Reducer device.

A year following the procedure, he described being able to ride a bicycle 35 miles on hilly terrain without angina. COSIRA-II is a clinical trial designed to evaluate the safety and effectiveness of the Reducer in treating patients suffering from refractory angina. The randomized, double blinded, placebo-controlled trial will enroll approximately 380 patients in the United States and Canada at as many as 50 investigational sites.

The primary endpoint of the trial is the change in exercise tolerance testing time measured at six months via a treadmill test.