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Atrial fibrillation (AF) and atrial flutter (AFL) are the most common cardiac arrhythmias worldwide.  A recently published report [Naccarelli GV, et al. Am J Cardiol. 2009 Dec 1] indicated that in 2005, approximately 3.0 million people in the US had AF only, another 0.07 million had AFL only, and 0.19 million had both AF and AFL. The same report indicated that as many as 600,000 new AF cases are diagnosed annually in the US. Independent industry researchers estimate further that AF affects 11 million people in the seven major world markets.

While not immediately life threatening, AF greatly increases the risk of stroke and premature death and is associated with significant morbidities and impaired quality of life.

Current therapies, including drugs, catheter and surgical ablation, external cardioversion and various types of surgical procedures and devices, do not adequately meet patient needs. A 2009  EU medical journal article reported that, “Unfortunately, current treatment strategies aiming at the elimination of atrial fibrillation have limited long term success rates and significant risks.”

Pain-free, low-energy implantable atrial cardioverters are expected to provide cardiologists and cardiac electrophysiologists with another effective therapy option in selected patient types and in certain types and/or stages of the disease.

Pain-free atrial cardioverters are also expected to lower drug dosage levels and extend the effectiveness of certain AF procedures. In addition, they should help reduce the significant costs of treatment associated with AF, estimated by the Centers for Disease Control (CDC) to have reached $6.65 billion by 2005.