DevicePMAs@therightstef:P830060_S000 / 6-16
|
Approval for the Automatic Implantable Cardioverter Defibrillator (AICD). The device is indicated for the treatment of ventricular tachycardia and ventricular fibrillation in those patients who are at high risk of sudden cardia death. Such patients are defined as (1) those who have survived at least one episode of cardiac arrest presumably due to hemodynamically unstable ventricular tachyarrhythmia not associated with acute myocardial infarction, and (2) those who, in the absence of such previous arrest, have experienced recurrent ventricular tachyarrhythmias and are inducible into sustained hypotensive ventricular tachycardia and/or fibrillation despite conventional antiarrhythmic drug therapy. The patients who meet the above criteria should have also undergone a complete cardiological evaluation that includes electrophysiological testing.
|