ARLINGTON, Va., May 7, 2002---The Food and Drug Administration (FDA) has approved the first implantable device for heart patients that acts as both a defibrillator and a cardiac resynchronizer.

The dual device can be used against advanced heart failure in certain patients who already need an implantable cardioverter defibrillator. These are patients whose heart timing is off and who, despite medication, show signs of advanced heart failure, such as shortness of breath and difficulty with daily activities.

The Contak CD CRT-D, made by Guidant Corp. of Indianapolis, detects and treats abnormal, life-threatening heart rhythms, while also coordinating the beating of left and right ventricles so they pump more effectively.

FDA approval followed a six-month study in which two groups totaling 708 patients received the device. Half had both functions activated, the other half had only the defibrillator turned on. Patients with both functions of the device activated reported better energy and quality of life compared with the other group. Survival rates were not assessed.

A post-marketing study of 1,000 patients over three years will examine survival rates and long-term safety.

[ MORE ]