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 daily basis.
"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 heart.
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 doctor's office.
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.