Abbott collects European, US clearances for heart ablation catheters

Abbott collects European, US clearances for heart ablation catheters

Abbott scored two device approvals for its cardiac ablation catheters for treating abnormal heart rhythms—one on each side of the pond.

In Europe, the company received a CE Mark for its Tactiflex ablation catheter, equipped with a soft, sensor-enabled tip designed to help surgeons map out the areas of the heart where errant electrical signals cause it to beat off-cue.

Designed to treat conditions such as atrial fibrillation—the most common heart arrhythmia, affecting millions of people—the company said the device’s first procedures were performed in the U.K. and Germany.

Used with Abbott’s EnSite X electrophysiology mapping system to collect 3D data of the heart, the tip of the TactiFlex catheter is cut in a certain way that allows it to fold when it is pushed against the interior of the heart wall—keeping it in place when delivering ablations and directing cooling irrigation to its target. Though currently undergoing FDA review, the TactiFlex is available in Europe, Africa, Japan and Australia.

Meanwhile, in the U.S., the FDA expanded the usage of the TactiFlex’s older sibling, the FlexAbility catheter, a similarly sensor-enabled device that helps surgeons identify the electrical paths behind certain arrhythmias.

After previously being approved for atrial flutter, the agency’s new green light broadens the catheter’s reach into ventricular tachycardia (VT), and specifically among patients who have a swelling of the heart muscle known as non-ischemic cardiomyopathy, which weakens its ability to pump blood efficiently.

The super-fast heart rhythm can lead to cardiac arrest if left untreated. According to the company, a clinical trial of the FlexAbility ablation catheter found that 80% of patients were free from VT for at least six months after the procedure.

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