HeartWare International (NSDQ:HTWR) plans to start marketing its implantable heart pump in Canada as a bridge to transplant for patients with end-stage heart failure, in the wake of a regulatory sign-off for the device.
The Framingham, Mass.-based company said today that Health Canada approved its left ventricular assist device. President & CEO Doug Godshall said the company is now looking forward to "demonstrating the benefits of the HeartWare System in a larger patient population in Canada.”
HeartWare won FDA approval for the system in 2012 for the bridge-to-transplant indication and in won nods 2011 in Europe and Australia.
More than 8,000 advanced heart failure patients have received the HeartWare device, according to the company.
In February, the company issued an urgent recall for certain computerized controllers used for its heart pump, based on worries of a possible malfunction that could cause the pump to stop working. The recall affected controllers distributed before its ventricular assist device won FDA approval in 2012.