Approval Order Statement
Approval for the Medtronic Transvene® Lead System. This device is intended for single long-term use and each lead is designed to be used only with a compatible Medtronic implantable tachyarrhytmia control device along with at least one other Medtronic defibrillation lead. The lead system has application where implantable e tachyarrhythmia cardioversion or defibrillation systems are indicated. Current medical research indicates that such patients should: (1) have survived at least one episode of a cardiac arrest presumably due to a ventricular tachyarrhythmia as evidenced by resuscitation using a transthoracic defibrillator. The ventricular tachyarrhythmia should not be caused by an acute myocardial infarction; or (2) in the absence of a of a prior cardiac arrest, have poorly tolerated sustained VT and/or VF, which occurs spontaneously, or can be induced, despite the best antiarrhythmic drug therapy.The natural history of patients with hemodynamically stable sustained VT is not well defined. While this patient population was included in the Transvene® Lead clinical study, no conclusions were drawn from the data obtained on this specific patient group.Prior to Transvene® implant, it is strongly recommended that patients undergo a complete cardiac evaluation, which should include extensive electrophysiologic testing. Also, extensive electrophysiologic evaluation and testing of the safety and efficacy of the proposed pacing, cardioversion, or defibrillation therapies are recommended during and after the implantation of the Transvene® System. |
