Abbott Laboratories announced that its TactiFlex™ Duo Ablation Catheter has received CE Mark approval, allowing the device to be sold throughout the European Union for the treatment of atrial fibrillation. The approval, granted on January 20, 2026, follows the company’s 2025 FDA clearance of the Volt PFA System and represents the third major regulatory milestone for Abbott’s pulsed‑field ablation (PFA) portfolio.
The TactiFlex Duo is a dual‑mode catheter that can deliver both radiofrequency (RF) and pulsed‑field energy during a single procedure. This flexibility lets electrophysiologists tailor therapy to each patient’s anatomy and arrhythmia substrate, potentially improving lesion quality and reducing procedural time. The device also integrates with Abbott’s EnSite™ X EP System, providing high‑resolution 3‑D cardiac mapping to guide precise ablation.
Market analysts project the European AFib system market to grow from USD 4.6 billion in 2025 to USD 8.9 billion by 2031, a CAGR of 11.1%. Abbott’s new approval positions the company to capture a larger share of this expanding market, especially in complex cases where dual‑energy capability offers a competitive advantage over single‑mode competitors such as Medtronic, Boston Scientific, and Johnson & Johnson.
Chief Medical Officer Christopher Piorkowski said the dual‑energy feature “provides clinicians with unprecedented flexibility, enabling them to switch between RF and PFA in real time to optimize lesion formation.” He added that the CE Mark approval “expands our footprint in Europe and strengthens our portfolio against the growing PFA competition.” Professor Isabel Deisenhofer, a leading electrophysiology researcher, noted that the device’s ability to combine RF and PFA “could improve patient outcomes by reducing collateral damage while maintaining effective ablation.”
The approval follows data from Abbott’s FOCALFLEX CE Mark study, which demonstrated the safety and efficacy of the TactiFlex Duo in a European patient cohort. The study’s positive results, combined with the device’s dual‑mode capability, were key factors in the European Medicines Agency’s decision to grant CE Mark status.
Abbott’s electrophysiology business has already generated significant revenue from its original TactiFlex RF catheter, contributing approximately $2.46 billion in 2024 sales. The new CE Mark approval is expected to accelerate growth in the segment, reinforcing Abbott’s strategy to expand its PFA offerings and compete more aggressively in the high‑growth AFib market.
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