Market & Opportunity

Atrial fibrillation (AFib) is a condition that causes an irregular heart beat (arrhythmia) due to a malfunction in the heart’s electrical system. For people with AFib, the heart’s upper chambers beat irregularly and out of sync with the lower chambers.

According to Circulation Research, AFib is associated with a 5x increased risk of stroke, 3x increased risk of heart failure and 2x increased risk of death.

Medication is the first line of treatment, yet 1 in 2 people are unresponsive to medication. For the 35 million people worldwide with persistent AFib, the only alternative is a catheter-based therapy known as pulmonary vein isolation (PVI) that scars the heart tissue and prevents the abnormal electrical signals originating in the four pulmonary veins from traveling to the left upper chamber of the heart. PVI allows the heart’s normal rhythm to return.

 

The leading PVI technologies use either heat (RF) or cold (cryotherapy) to ablate the heart tissue and isolate the problematic electrical signals.

 

Ablating with RF heat technology requires painstaking point-by-point ablation around each pulmonary vein.  It may give the doctor the ability to ablate any particular tissue, but it takes several hours and often fails to create a full isolation of the pulmonary veins.  Ablating with cooling technology requires fixed-sized balloons that more rapidly ablate tissue in a one-shot procedure but cannot fully address the anatomical differences among different patients and their pulmonary veins.

 

The result: existing AFib ablation solutions are associated with a one-year failure rate of up to 30%; recurrent AFib; and repeat ablation procedures.

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More effective

Catheter self adjusts to individual anatomy improving tissue contact

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2 in 1

Combining focal and one-shot ablation

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Faster & Easier

Estimated under 30min

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Safer

Lower complication rates