Health Canada grants marketing approval for HeartWare Ventricular Assist System

9 April 2015 (Last Updated April 9th, 2015 18:30)

Health Canada has granted marketing approval for US-based HeartWare International's Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.

Heartware

Health Canada has granted marketing approval for US-based HeartWare International's Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.

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

Peter Munk Cardiac Centre chief of Cardiovascular Surgery Vivek Rao said: "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.

"The system features the HVAD Pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding abdominal surgery generally required to implant competing devices."

"With Health Canada approval, we look forward to continuing our positive experience with this device."

In 2012, US Food and Drug Administration (FDA) approved the HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.

St Paul's Hospital director of Cardiac Transplant 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.

"Since 2010, we have 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."

The system obtained CE Mark approval in the European Union in 2009 and Australian Therapeutic Goods Administration (TGA) approval in 2011.

HeartWare International CEO Doug Godshall said: "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."

Currently, more than 8,000 advanced heart failure patients worldwide have received the HVAD Pump.


Image: The HeartWare Ventricular Assist System featuring the HVAD Pump. Photo: courtesy of PRNewswire / HeartWare International Inc.