Atrial Fibrillation Backgrounder

Atrial Fibrillation Backgrounder

The IRIS™ System is designed for the treatment of complex cardiac arrhythmias, specifically Atrial Fibrillation (AF).

AF is the most common sustained cardiac arrhythmia. It is responsible for significant morbidity and healthcare costs including repeat hospitalization. There are approximately 2.2 million people with AF in America alone and these patients represent over $6.5 Billion dollars in health care costs per year.

In AF, the atria contract in a fast, chaotic manner resulting in loss of coherent contraction or "quivering" of the atrial chambers (350-600 atrial beats/minute).

The disease state can be thought of as a spectrum with three main categories:

  • Paroxysmal (intermittent) – Atrial Fibrillation that lasts from a few seconds to days, but terminates on its own within a week
  • Persistent and long-standing persistent – Atrial Fibrillation that does not self terminate and fibrillation episodes may last from weeks to months. The heart may need to be converted back to sinus rhythm with medication or direct current cardioversion
  • Permanent – Conversion back to sinus rhythm is not possible

While cases may not always manifest in clinical symptoms, many patients experience a significantly diminished quality of life. In addition, long-term clinical consequences can be serious, as patients with AF face an elevated risk of complications including stroke (5x increase), congestive heart failure, and/or sudden cardiac death.

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