Health Canada has approved Heartware’s HVAD ventricular assist system as a bridge to heart transplant for patients with end-stage heart failure, the Framingham, Mass., devicemaker announced Thursday.
The system includes the HVAD Pump, which was developed to be implanted next to the heart without the usual required abdominal surgery. To that end, Heartware has initiated a clinical trial to study less invasive left thoracotomy surgical implantation.
The system has received FDA, CE Mark and TGA approval in 2012, 2009 and 2011, respectively. It is the first, full-support, miniaturized ventricular assist device designed to be implanted in the pericardial space to gain Canadian approval, the company said.
More than 8,000 heart failure patients have been implanted with the HVAD Pump worldwide. — Jason Scott