This document addresses intracardiac ischemia monitoring which utilizes an implantable electrogram device that records cardiac data and detects ischemic events using a standard pacemaker intracardiac lead positioned in the right ventricular apex. This implantable warning system emits a vibrational alarm when impending acute ischemic events are detected prior to symptom onset. The device is currently intended only for use in individuals considered high risk for ischemic cardiac events, such as those with previous acute coronary events, diabetes, or renal insufficiency. The proposed purpose of the device is to reduce the time from ischemic event onset to presentation in an emergency room with proposed potential clinical benefits related to faster emergent care.

Position Statement

Investigational and Not Medically Necessary:

Intracardiac ischemia monitoring is considered investigational and not medically necessary for all indications including, but not limited to, detection of acute myocardial ischemic events.