Abbott’s TactiFlex Duo Catheter Earns CE Mark for Dual-Energy AFib Treatment
Abbott received CE Mark in Europe for its TactiFlex™ Duo Ablation Catheter, enabling both radiofrequency and pulsed field ablation for complex atrial fibrillation. The first commercial EU cases were completed this week, backed by FOCALFLEX CE Mark study results showing safety and effectiveness in AFib treatment.
1. Analyst Consensus Highlights Upside Potential
Over the past month, 18 Wall Street firms covering Abbott have issued fresh recommendations, raising the proportion of Buy ratings to 61% from 55% three months earlier. Analysts have revised full-year 2026 earnings per share estimates upward by an average of 4.2%, driven largely by strength in the company’s medical devices segment. Consensus revenue forecasts for fiscal 2026 now stand at $47.3 billion, up from $46.8 billion projected at the start of the year, reflecting improved guidance from Abbott’s cardiovascular franchise and robust growth in diabetes care products. Notably, three major brokerage houses – Morgan Stanley, JPMorgan and UBS – have all increased their 12-month share price targets on the basis of accelerating free cash flow generation and a shift toward higher-margin device offerings.
2. CE Mark Approval Bolsters Electrophysiology Pipeline
On January 20, Abbott secured the CE Mark for its TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, marking its third significant electrophysiology approval in under 12 months following U.S. and European clearances for the Volt PFA System in 2025. The dual‐energy catheter demonstrated a 95% acute success rate in the global FOCALFLEX CE Mark study, which enrolled 312 atrial fibrillation patients across 15 sites in Europe, the U.K. and Australia. Clinical investigators reported zero device‐related serious adverse events at 30 days and a 92% freedom from arrhythmia recurrence at three months post-procedure. With an estimated eight million Europeans over age 65 living with AFib and projected to double by 2055, Abbott expects TactiFlex Duo to contribute an incremental $350 million in sales in fiscal 2026, further strengthening its electrophysiology portfolio and supporting targeted mid-teens operating margin expansion.