150th implant, page-6

HeartWare completes enrolment in trial
September 3, 2007

Heart device maker HeartWare Ltd has completed the patient enrolment for the international clinical trial of its HVAD heart pump.

HeartWare has enrolled 20 patients, all suffering advanced heart failure, and awaiting cardiac transplantation.

The trial is taking place in Europe and Australia.

"Twenty patients have now been implanted with the HVAD device," HeartWare said.

"On a cumulative basis these patients have been supported for 3,000 days, or more than eight years.

"Eight patients have so far passed the primary endpoint of the trial."

The HVAD is a pump, designed as an alternative to a heart transplant.

The company hopes to achieve the commercial launch of the HVAD device in Europe early next year.

HeartWare is also pushing for regulatory approval of the HVAD device in the United States.