Abbott receives FDA clearance for TactiFlex Duo catheter, offering flexible AFib ablation options

Abbott announced that the U.S. Food and Drug Administration has cleared its new TactiFlex Duo catheter for use in atrial fibrillation ablation.

The catheter can deliver pulsed field ablation, radio-frequency energy, or a combination, and works with Abbott’s EnSite X EP System to give real-time mapping and a PFA Index that evaluates lesion formation.

Regulatory clearance relied on results from Abbott’s FlexPulse Identity study, which showed favorable outcomes for the device.

Clinicians say the added flexibility could improve safety and effectiveness of AFib procedures, a condition that affects millions of Americans.