First Fully Automatic Pacemaker Approved
New Pacemaker Adjusts Itself Without a Doctor's Help
March 19, 2004 -- A new type of automatic pacemaker approved
recently by the FDA promises to reduce the amount of time heart patients spend
in their doctor's office.
The Medtronic EnPulse system is the first fully automatic
pacemaker to be approved for use in the U.S. Unlike regular pacemakers that
require doctors to manually adjust the pacing, this device can regularly
measure and automatically adjust the level of pacing provided on an hourly or
"The EnPulse is the first pacemaker capable of performing a
complete set of diagnostic tests without human intervention," says Steven
Comptom, MD, an electrophysiologist at the Alaska Heart Institute in Anchorage,
in a news release.
An earlier version of the EnPulse pacemaker was approved last
year, but now the FDA has approved the use of EnPulse together with a new
feature called Atrial Capture Management (ACM). This feature allows the
pacemaker to automatically adjust electrical impulses delivered to the
Automatic Pacemaker Reduces Office Visits
The FDA also approved the use of the pacemaker with an
Internet-based remote cardiac device monitoring network, which is operated by
the manufacturer. The network allows patients to transmit information from
their pacemaker while at home or traveling rather than making a trip to the
Doctors can then review the information and make any necessary
adjustments to the patient's course of treatment.
Researchers say about 250,000 people receive pacemakers each
year. Most pacemakers help pace the heart when the natural rate is too slow to
meet the body's needs.
The EnPulse pacemaker with ACM has been available in Europe
since October 2003.