Approval Order Statement
Approval for the ventak(r) av(tm) aicd(tm) model 1810/model 1815 automatic implantable cardioverter defibrillator (aicd(tm) with the model 2833 software application. This device is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular arrhythmias and who have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia; recurrent, poorly tolerated sustained ventricular tachycardia (vt); prior to myocardial infarction, left ventricular ejection fraction of less than or equal to 35 percent, and a documented episode of nonsustained vt, with an inducible ventricular tachyarrhythmia. Patients suppressible with iv procainamide or an equivalent antiarrhythmic have not been studied. |
