New Clinical Studies Support Broader Use of CardioNet System for the Detection of Atrial Fibrillation


January 9, 2009

January 9, 2009 - CardioNet Inc. today announced the publication of two studies and the presentation of two abstracts that further support the broader use of the CardioNet System for the detection of atrial fibrillation (AF).

The studies demonstrate the CardioNet System’s ability to detect clinically significant AF events in patients following ischemic stroke or surgical AF ablation procedures. The CardioNet System allows the detection of any patients that relapse with AF events, both symptomatic and asymptomatic, therefore enabling the physician to prescribe additional treatment or drug therapy in cases where the AF has reoccurred.

The first study is titled “Atrial Fibrillation Detected by Mobile Cardiac Outpatient Telemetry in Cryptogenic TIA or Stroke,” authored by A.H. Tayal, M.D., Allegheny General Hospital, Comprehensive Stroke Center was published in the Nov. 18, 2008 issue of Neurology. The purpose of the study was to demonstrate the feasibility of detecting AF in patients with stroke of undetermined etiology through prolonged monitoring. The study concluded that the CardioNet System detected a high rate of AF (23 percent) in patients that have experienced a transient ischemic attack (TIA) or stroke for which the etiology was indeterminable through standard diagnostic evaluation methods.

“Our study showed that mobile cardiac outpatient telemetry had a high rate of AF detection, including asymptomatic and short events, which may be a biomarker of prolonged and clinically significant AF.” said Dr. Tayal. “Such patients may benefit from anticoagulation and may not have been diagnosed with AF through standard methods.”

Evelio Rodriguez, M.D., division of cardiothoracic and vascular surgery, Brody School of Medicine, East Carolina University, presented an abstract from a study titled “Cryo-Maze for Concomitant Atrial Fibrillation: Mid-Term Results using CardioNet Home Monitoring Testing” at the 46th Annual Meeting of the Pennsylvania Association of Thoracic Surgeons Oct. 3, 2008. The study utilized the CardioNet System for home monitoring of patients that underwent concomitant AF ablation to determine the efficacy of the procedure. The authors of the study noted that rhythm assessment after ablation with electrocardiogram (ECG) and/or Holter monitors has been shown to overestimate success, which led to their selection of the CardioNet System for the study. The study concluded that home monitoring with the CardioNet System should become standard of care after interventions performed to restore sinus rhythm in patients with AF.

Two additional studies utilized the CardioNet System for post-operative management and follow-up of patients that underwent surgical procedures to treat AF:

- “Toward a Definitive, Totally Thoracoscopic Procedure for Atrial Fibrillation” - authored by John Sirak, M.D., Ohio State University Department of Surgery, division of cardiothoracic surgery, Columbus, OH, published in the Dec. 8, 2008 issue of The Annals of Thoracic Surgery.

- “Surgical Correction Of Atrial Fibrillation With The Cryomaze Procedure: Long-term Outcomes Assessed With Continuous Outpatient Telemetry” - abstract presented by James Gammie, M.D., University of Maryland Medical Center, at the Southern Thoracic Surgical Association 55th Annual Meeting on Nov. 6, 2008.

To date there have been 19 published clinical papers and abstracts on the capabilities and efficacy of the CardioNet System. This includes the landmark study that demonstrated the CardioNet System to be nearly three times better in diagnosing clinically significant arrhythmias as compared to loop event monitoring.

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