Canada OKs device by HeartWare of Framingham
Framingham-based HeartWare International has received approval to market an implanted heart device in Canada.
The product, called the Ventricular Assist System, approved by the U.S. Food and Drug Administration in 2012, is implanted as a bridge to heart transplant surgeries in patients with end-state heart failure. The company announced the agreement with the Canadian government’s Health Canada department on Thursday.
The HeartWare product features a small, full-support circulatory assist pumping device designed to be implanted next to the heart, allowing the patient to avoid the abdominal surgery generally required to install competing devices, HeartWare said in the statement.
"We are grateful for the efforts of the leading heart failure specialists in Canada who have worked diligently to gain an understanding of the attributes of the HeartWare System and share insights as we worked toward commercial approval," Doug Godshall, HeartWare’s president and CEO, said in the statement. "We look forward to demonstrating the benefits of the HeartWare System in a larger patient population in Canada, as we gain commercial experience with this device in an important new geography."
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