The Need

Arrhythmias-associated medical costs will exceed $50 billion by 2035, with AF placing the most strain on healthcare systems. Each year, there are more than 1.2 million AF episodes in the US, which will rise to 2.6 million by 2030. Each year, there are more than 750,000 hospitalizations. Medical and indirect costs currently are nearly $24 billion and $7 billion, respectively, which will exceed $50 billion and $10 billion by 2035. Nearly 80% of AF patients will be admitted to a hospital over the course of their disease. Although antiarrhythmic drugs are mainly used to restore rhythm, their use is associated with high failure rates (>35%) and long-term side effects. In contrast, catheter ablation has been shown to be more effective and is increasingly used to restore sinus rhythm, with growing support for ablation as a first-line therapy. Improved catheter navigation techniques and new technologies have improved lesion quality, which has reduced arrythmia recurrence rates by ~15% over the last decade. More than 500,000 catheter ablation procedures were performed in the US between 2000 and 2013, which has since grown exponentially. Currently, it is estimated that nearly 360,000 annual cardiac ablation procedures are performed in the US, of which 240,000 are used to treat AF.

Although current robotic and magnetic navigation systems address some gaps, these systems remain burdened by fundamental EP catheter mechanical limitations which frustrate accurate navigation and application of proper heart-wall forces. In general, these technologies have high learning curves, with magnet navigation systems also requiring a custom C-arm and EP suite due to the high magnetic fields they employ. In general, only high-volume centers can afford these prohibitively-expensive systems despite that more than 80% of all hospitals are lower-volume centers providing ~40% of all ablations.