CardioNet received FDA marketing clearance for the CardioNet Ambulatory Monitor with Arrhythmia Detection in February 2002. The current Indications and Contraindications are listed below.

Indications for Use
  • Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, incuding after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
  • Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath).
  • Patients with palpitations with or without known arrhythmias to obtain correction of rhythm with symptoms.
  • Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).
  • Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
  • Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias.
  • Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter.
  • Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes.
CardioNet is contraindicated for use in the following patients:
  • Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
  • Patients who the attending physician thinks should be hospitalized.
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