Neovasc's Reducer Device Launched in Select European Countries

March 19, 2015—Neovasc Inc. announced that the Reducer device for the treatment of refractory angina has been introduced to select centers in Italy and will soon be available for routine use at additional sites in Germany, the United Kingdom, and Switzerland. To support the commercial launch across Europe, Neovasc is initiating a multinational European REDUCER-I postmarket study to collect long-term clinical data on patients treated with the Reducer.

The Reducer treats refractory angina by altering blood flow in the heart, thereby increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Transvenous placement of the Reducer can be completed in approximately 30 minutes.

The first two Italian cases with the device were performed by Antonio Colombo, MD. Dr. Colombo is Director, Cardiac Catheterization Lab and Interventional Cardiology Unit, EMO GVM Centro Cuore, Columbus and San Raffaele Hospital in Milan, Italy. He reported his initial procedural experience with the Reducer as straightforward and that this therapy is a significant addition to the treatment of patients with refractory angina in the company's press release.

In February, the company announced that the final results from its COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) study were published by Stefan Verheye, MD, et al in The New England Journal of Medicine (2015;372:519-527). The COSIRA study, which assessed the efficacy and safety of the Neovasc Reducer for treatment of refractory angina, met its primary endpoint, demonstrating the efficacy of the device in relieving angina symptoms. The balloon-expandable, stainless steel, hourglass-shaped, coronary sinus-reducing device creates a focal narrowing and increases pressure in the coronary sinus, thus redistributing blood into ischemic myocardium, noted the investigators in NEJM.