HeartWare releases clinical trial data

November 10, 2009 by MassDevice staff

A study of the Framingham, Mass.-based firm's miniature heart pump shows a 90 percent survival rate six months after implantation.

HeartWare International Inc. released data from a clinical trial of its miniature heart pump in patients with end-stage heart failure, showing survival rates of 90 percent and 84 percent after six months and two years, respectively.

The Framingham, Mass.-based firm's left ventricular assist device is designed to provide a bridge to heart transplant patients, improving their cardiac function while they await a donor organ.

Data collected from a 50-patient trial aimed at winning CE Mark approval in the European Union (which was granted in January) showed a six-month survival rate of 90 percent, according to a regulatory filing. Two years after implantation the survival rate was 84 percent. Patients 60 years and older had a survival rate of 93 percent.

The study also showed an 80 percent reduction in post-implantation re-hospitalizations in the 12 months after the procedure, compared with the 12 months preceding implantation.

Eight patients who received the device died, four from multi-organ failure, two from sepsis and two from hemorrhagic stroke.

HeartWare is running a similar study in the U.S., aimed at winning Food & Drug Administration clearance. The FDA granted an interventional device exemption for the clinical trial, which is targeting 150 patients at 28 centers. As of August 21, 16 centers were enrolled and the device had been implanted in 50 patients.