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Approval for clarifications to the indications for use statements related to the optivol feature and other modifications to the device labeling. the devices are indicated as follows: dual chamber icdsthe dr system is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the device is indicated for use in the above patients with atrialtachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. Notes: 1) the use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias. 2) the effectiveness of high-frequency burst pacing (atrial 50 hz burst therapy) in terminating device classified atrial tachycardia (at) was found to be 17%, and in terminating device classified atrial fibrillation (af) was found to be 16.8%, in the vt/at patient population studied. 3) the effectiveness of high-frequency burst pacing (atrial 50 hz burst therapy) in terminating device classified atrial tachycardia (at) was found to be 11.7%, and in terminating device classified atrial fibrillation (af) was found to 18.2% in the af-only patient population studied. single chamber icds: the vr system is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
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