-- CE Marking Allows the Neovasc Reducer to Be Marketed in Europe for Disabling Cardiac Condition Lacking Treatment Options --
-- Neovasc Will Continue Patient Enrollment in the COSIRA Trial While It Prepares for European Commercialization --
TSX Venture Exchange: NVC
Nov. 14, 2011
/PRNewswire/ - Neovasc Inc. (TSXV: NVC), today announced that it has received the CE mark designation for its Reducer™ product for the treatment of refractory angina. CE marking confirms that the Reducer conforms to the applicable European Directive and allows the product to be marketed for implantation in patients in all member states of the European Union, the European Economic Area and
The Neovasc Reducer is a novel device designed to treat the millions of patients worldwide who suffer from refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle. Refractory angina currently affects an estimated one million patients in
, who often lead severely restricted lives. The incidence of refractory angina is growing, yet current treatment options are limited.
, MD, professor of medicine and system chair for cardiovascular diseases, the Ochsner Clinical School,
University of Queensland
, and medical director,
John Ochsner Heart
& Vascular Institute, Ochsner Medical Center, commented, "The Reducer appears to be a very promising tool for treating patients with the disabling ischemic chest pain known as angina. Achieving the European CE mark will allow this technology to be used in 'real world' patients and sets the stage for much needed clinical trials in the US."
The Reducer is implanted in the coronary sinus vein using minimally invasive techniques that are similar to implanting a coronary stent. By modulating blood flow from the coronary sinus—the main vein exiting the heart—the Reducer acts to increase the perfusion of oxygenated blood to certain areas of the heart muscle, thereby reducing the pain and disability caused by the condition.