HeartWare International has obtained approval from Health Canada for its Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.
The system includes HVAD Pump, a small full-support circulatory assist device developed to be implanted next to the heart. This helps to avoid the abdominal surgery generally required to implant competing devices, according to HeartWare.
University of British Columbia surgery professor and St. Paul’s Hospital cardiac transplant director Anson Cheung said: "Approximately the size of a golf ball, the small HVAD Pump allows for ease of implantation and pursuit of less invasive surgical approaches."
In 2012, the system received approval from the US Food and Drug Administration (FDA) as a bridge to heart transplantation in patients with end-stage heart failure.
It obtained CE mark approval in the Union in 2009 and Australian Therapeutic Goods Administration (TGA) approval in 2011.
HeartWare International president and CEO Doug Godshall said: "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.
"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."
Image: HeartWare Ventricular Assist System has obtained approval from Health Canada. Photo: courtesy of HeartWare International, Inc.