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Results from the FlexPulse IDE study showed that Abbott’s TactiFlex Duo catheter, which combines pulsed-field ablation and radiofrequency ablation, achieved efficacy and safety after one year of treating patients with paroxysmal atrial fibrillation. The company plans to use the data as the basis for submitting an application to the FDA to market the catheter in the United States.
Abbott has received the European CE mark for the Amulet 360, an upgraded version of its device for closing the left atrial appendage in certain patients with atrial fibrillation in order to reduce the risk of stroke. The company is preparing to expand the device’s use in European countries in the coming weeks, amid direct competition with Boston Scientific’s Watchman device.