HeartWare Device Met Study Goal Keeping Most Patients Alive
November 14 2010 - 3:53PM
Dow Jones News
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;
jennifer.corbett@dowjones.com
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