New Pacemaker Device Gets FDA Approval to Treat Heart Failure
Aug. 28, 2001 (Washington) -- The FDA
approved a novel type of pacemaker Tuesday, which could offer new hope to
thousands of patients who have heart failure.
With the government's approval today,
Medtronic Inc.'s InSync technology will become available to appropriate
patients in September, says Marshall Stanton, MD, medical director of the
company's cardiac rhythm management business.
People with the disease have a weakened
heart that is unable to pump enough blood for the patient to stay healthy. The
weakening can happen as a result of a heart attack, high blood pressure, and
infection, as well as unknown reasons. Patients gradually lose their ability to
be active and can become so short of breath and fatigued that, eventually, any
movement becomes difficult. Half of the patients with the disease don't live
more than five years.
Doctors can use many different types of
drugs to make it easier for the heart to pump blood. But while medication can
be used to lighten the load on the heart, some complications of heart failure
can't be treated with drug therapy.
Stanton says of the 5 million people with
heart failure in the U.S., about a third develop a problem where the heart
becomes even less efficient. The two pumping chambers in the heart that take
turns filling up and squeezing out blood to the body no longer work in the
The InSync system, he says, is designed to
help get the different parts of the patient's heart working together again. The
InSync pacemaker delivers an electrical impulse -- from a small pulse generator
implanted in the chest -- down three wires attached to the heart -- that makes
the heart's pumping chambers work together.
The patient probably will still have some
degree of heart failure, he says, but the device helps doctors to regain some
of the heart's pumping performance. And that could mean that a person could be
more active, breathe easier, and feel less fatigued.
The technique is called cardiac
resynchronization and cardiologists estimate it could help some 750,000
advanced heart failure patients who can't be helped by today's best
Pacemakers are widely used to get hearts
that beat too slowly or irregularly into a normal rhythm. Medtronic's souped-up
pacemaker works another way, boosting the beats of weak hearts. Medtronic beat
two competing companies to get the device to market.
"It's a big breakthrough," said
David B. DeLurgio, MD, an Emory University cardiologist who helped test the
device for Medtronic. "It's not for every heart failure patient, but a
proportion could definitely benefit."
In a study of 579 patients, those using the
pacemaker experienced significant improvement, FDA reviewers concluded in
approving the device.
One standard heart failure test measures
how far patients can walk in six minutes. Those whose pacemakers were turned on
could walk, on average, 58 more yards than patients in a comparison group whose
pacemakers were turned off.