New Defibrillator Implanted Just Under the Skin

powered by healthline

Average Ratings

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.


-- Scott Roberts
Copyright © 2012 HealthDay. All rights reserved.
Article from
Top of page
General Drug Tools
General Drug Tools view all tools
Tools for
Healthy Living
Tools for Healthy Living view all tools
Search Tools
Search Tools view all tools
Insurance Plan Tools
Insurance Plan Tools view all tools

What is a reference number?

When you register on this site, you are assigned a reference number. This number contains your profile information and helps UnitedHealthcare identify you when you come back to the site.

If you searched for a plan on this site in a previous session, you might already have a reference number. This number will contain any information you saved about plans and prescription drugs. To use that reference number, click on the "Change or view saved information" link below.

You can retrieve information from previous visits to this site, such as saved drug lists and Plan Selector information.