But it's still designed to correct an irregular heartbeat
FRIDAY, Sept. 28 (HealthDay News) -- The first defibrillator that doesn't require a hard-wired connection to the heart has been approved by the U.S. Food and Drug Administration, the agency said Friday in a news release.
Standard defibrillators -- designed to deliver an electric pulse and suppress a rapid or irregular heartbeat -- have used an electrical wire called a lead that's inserted through a vein directly into the heart.
The S-ICD system, by contrast, uses a lead that's implanted just below the skin along the bottom of the rib cage. It's not sanctioned for people who require a pacemaker, the FDA warned.
Approval was based on a 321-person study in which 78 cases of spontaneous arrhythmia (irregular heartbeat) were either resolved by the defibrillator or resolved on their own, the FDA said.
The device manufacturer -- San Clemente, Calif.-based Cameron Health Inc. -- must conduct a
five-year post-approval study on the defibrillator's long-term safety and effectiveness, the agency said.
More information
To learn more about heart defibrillators, visit the U.S. National Heart, Lung, and Blood Institute.
Copyright © 2013
HealthDay. All rights reserved.
HealthDayNews articles are derived from
various sources and do not reflect federal policy. healthfinder.gov
does not endorse opinions, products, or services that
may appear in news stories. For more information on
health topics in the news, visit
Health News on healthfinder.gov.
