India Pharma Outlook Team | Thursday, 22 January 2026
Abbott today announced it has received CE Mark approval in Europe for the Abbott TactiFlex Duo Ablation Catheter, Sensor Enabled, expanding treatment options for patients with atrial fibrillation (AFib).
Following the approval, the first successful commercial cases using the catheter were completed this week across the European Union.
The Abbott TactiFlex Duo Ablation Catheter is the newest addition to the company’s pulsed field ablation (PFA) portfolio. Cardiac ablation depends on creating precise lesions to block abnormal heart signals. TactiFlex Duo gives physicians two energy options in one catheter: radiofrequency ablation, which uses heat, and pulsed field ablation, which uses high-energy electrical pulses to target heart tissue while reducing the risk of damage to nearby structures.
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"TactiFlex Duo's most unique feature is its dual options that allow physicians to seamlessly switch treatment during a procedure based on the patient's personalized needs and anatomy," said Prof. Isabel Deisenhofer, M.D., head of the department of electrophysiology at the German Heart Center Munich in Germany.
The CE Mark was supported by Abbott’s global FOCALFLEX study, conducted across Europe, the United Kingdom, and Australia, which showed strong safety and effectiveness results in AFib patients.
Around eight million Europeans over 65 live with AFib, a number expected to double over the next 30 years. "AFib is a progressive disease that becomes harder to treat over time, and there is not a one-size-fits all approach, which makes long-term management complex," said John Silberbauer, M.D., electrophysiologist at the Sussex Cardiac Centre.
TactiFlex Duo integrates with Abbott’s EnSite X EP System for detailed 3D heart mapping and marks Abbott’s third major electrophysiology approval in under a year, following the Volt PFA System.
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