DevicePMAs@therightstef:P910023_S000 JSONTXT 11 Projects

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.