Cadence(R) Tiered Therapy Defibrillation System

Approval order statement

Approval for the Cadence® Tiered Therapy Defibrillator System. This device is indicated for use in patients with a history of hemodynamically compromising ventricular tachyarrhythmias. These patients may have experienced a cardiac arrest not associated with acute myocardial infarction or have ventricular tacharrhythmias. In addition, the Cadence® can be used in patients whose primary therapy for hemodynamically significant, sustained ventricular tachycardia is antitachycardia pacing; the defibrillation capabilities of the device provide high energy therapy in the event that the arrhythmia accelerates. The Cadence® is intended for use with the defibrillation lead systems with which it has been tested: Ventritex epicardial defibrillation leads, and commercially available CPI defibrillation patch leads and superior vena cava (SVC) spring leads. When used with the CPI patch lead or SVC leads, the Cadence® is intended for use as a replacement for CPI automatic implantable cardioverter defibrillators.