FRIDAY, May 16, 2003 (HealthDayNews) -- The U.S. Food and Drug Administration has approved an implantable cardioverter defibrillator (ICD) that is considerably less expensive than those already on the market.
A surgically installed ICD monitors a person's heart rhythm and generates an electric shock when it senses an unusual heartbeat (arrhythmia). The $10,000 price tag on the new product, made by Biotronik of Portland, Ore., is about half that of standard ICDs, the FDA says.
While not as fully featured, it is easier to program and simpler to use than standard models, the agency adds.
As a condition of approval, the FDA is requiring Biotronik to conduct an additional two-year study of 370 patients in whom the device is already implanted.
For more information about heart arrhythmia, visit the National Library of Medicine.
