HeartWare International gets approval to market HeartWare Ventricular Assist System in Canada

HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that it has received approval from Health Canada, the country's federal department responsible for helping Canadians maintain their health, to market the HeartWare^® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.

"We gained valuable experience with the HeartWare^® System under Health Canada's Special Access program and found it to be an important addition to our treatment options, particularly with difficult-to-treat patients," said Vivek Rao, M.D., Ph.D., M.S., FRCSC, Chief of Cardiovascular Surgery and Director of Mechanical Circulatory Support at the Peter Munk Cardiac Centre, University Health Network in Toronto. "With Health Canada approval, we look forward to continuing our positive experience with this device."

The HeartWare Ventricular Assist System features the HVAD^® Pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.

"Approximately the size of a golf ball, the small HVAD Pump allows for ease of implantation and pursuit of less invasive surgical approaches," said Anson Cheung, M.D., B.S., M.S., FRCSC, Director of Cardiac Transplant at St. Paul's Hospital in Vancouver, and Professor of Surgery at the University of British Columbia. "Since 2010, we've been able to build an extensive and positive clinical experience with the HVAD Pump. Earlier this year, we commenced LATERAL, a clinical trial to examine the potential benefits of implanting this device through a less invasive left thoracotomy technique, as an alternative to the sternotomy approach associated with many cardiac surgeries."

"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," said Doug Godshall, President and CEO at HeartWare. "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."

The HeartWare Ventricular Assist System received U.S. Food and Drug Administration (FDA) approval in 2012 as a bridge to heart transplantation in patients with end-stage heart failure. The HeartWare System has been the leading ventricular assist device implanted in patients outside of the United States for the last three years, having received CE Marking in the European Union in 2009 and Australian Therapeutic Goods Administration (TGA) approval in 2011. Today, more than 8,000 advanced heart failure patients globally have received the HVAD Pump.