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New Defibrillator Implanted Just Under the Skin
But it's still designed to correct an irregular heartbeat By Scott Roberts
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 © 2012 HealthDay. All rights reserved. URL:http://www.healthscout.com/template.asp?id=669140
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