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FDA APPROVES NEW TYPE OF DEFIBRILLATOR

FDA today approved a new type of implantable cardioverter defibrillator (ICD) that also has the ability to deliver cardiac resynchronization therapy. The device, the first of its kind, can be used to treat symptoms of advanced heart failure in certain people who already need an ICD.

The product, the Contak CD CRT-D made by Guidant Corp., of Indianapolis, Ind., combines an implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT). The defibrillator component detects and treats life-threatening heart rhythms. The CRT component coordinates the beating of the left and right ventricles of the heart so that they work together more effectively to pump blood throughout the body.

The device is intended to treat people who already need an implantable defibrillator, whose heart timing is off and who, despite taking heart failure medication, have symptoms of advanced heart failure, such as fatigue, shortness of breath and difficulty performing daily activities.

FDA based its approval on the results of two multi-center clinical studies conducted in the United States by Guidant. In the first study, 581 patients received the Contak system. In the second study, 127 patients received it. In half the patients, only the defibrillator component was turned on. In the other half, both the defibrillator and the CRT components were turned on. Both groups were studied for six months.

The studies showed that the Contak system is safe and effectively coordinates the beating of the heart's ventricles, resulting in an improvement in some of the symptoms of heart failure. Patients in whom both components were turned on had a better quality of life and improved exercise capacity than those in whom just the defibrillator was turned on. The studies did not show whether or not the device ultimately affected patient survival.

FDA is requiring Guidant to conduct a post marketing study of 1,000 patients over three years to determine the product's effect on mortality and to better assess its long-term safety.

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