HeartWare Device Met Study Goal Keeping Most Patients Alive

An experimental heart-pump device being developed by HeartWare International Inc. (HTWR) was able to keep more than 90% of patients alive six months after receiving the device, according to a study released Sunday.

The results, which will be presented Sunday at the American Heart Association's annual meeting, met a study goal showing that the device worked as well as other heart-pumping devices such one by Thoratec Corp. (THOR).

HeartWare's Ventricular Assist System is a device that's implanted inside a person to help people with severe heart failure. The device, known as a left ventricular assist device, helps a damaged heart pump blood. The product is approved in Europe and HeartWare plans to seek approval in the U.S. later this year for patients awaiting a heart transplant.

Left ventricular assist devices were originally designed to help patients survive until they could receive a heart transplant. Earlier this year, however, Thoratec received approval from the Food and Drug Administration to use the device in severely ill heart-failure patients who can't receive a heart transplant.

The American Heart Association estimates that about 2,100 heart transplants are performed annually in the U.S., and that there are about 150,000 patients with advanced heart failure. In earlier stages of heart failure, patients are managed with medication or other devices such as defibrillators, but as the disease progresses there are few treatment options.

The study of HeartWare's device involved 140 patients who received the device from March 2009 through February 2010. The patients were compared to a group of 499 patients from a nationwide listing of heart-failure patients who received commercially available left ventricular assist pumps during the same period.

Researchers compared survival and success rates between the two groups of patients at 180 and 360 days after implantation. The study showed 92% of patients receiving HeartWare's device survived for 180 days compared to 90% of patients who received other devices.

About one year after implantation, 91% patients with HeartWare's device survived compared to 86% of patients receiving other devices, a difference that's not considered statistically significant.

The study's lead author, Keith Aaronson, medical director of the Heart Transplant and Mechanical Circulatory Support Programs at the University of Michigan Medical Center in Ann Arbor, said patients receiving the device also experienced quality-of-life improvements similar to those seen among patients getting heart transplants.

"These patients don't just survive to a transplant, they feel better and can be much more active," he said explaining that patients were able to walk further on a six-minute walk test after receiving the device.

HeartWare's device is considered a third-generation device and is smaller and easier to implant than current devices on the U.S. market, researchers said.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]