New Defibrillator Implanted Just Under the SkinLast Updated: September 28, 2012.
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.
To learn more about heart defibrillators, visit the U.S. National Heart, Lung, and Blood Institute.