New Antiarrhythmia Devices — FDA’s Requirements for Effectiveness

Summary

Many antiarrhythmia devices are now either being marketed or are under clinical investigation in the United States. These devices include traditional pacing systems such as inhibited single and dual chamber pacemakers (AAI, WI, DVI and DDD) for the control of bradyarrhythmias and for overdrive suppression of certain tachyarrhythmias. The newer burst pacing systems and implantable cardioverters are being studied for control of both supraventricular and ventricular tachycardia and for control of ventricular tachycardia and fibrillation. To establish effectiveness, FDA requires that the manufacturer demonstrate that the pacing system provides the benefits claimed in the labeling. The data required to demonstrate the effectiveness for each of these types of pacing systems are discussed.