The Investor
31 Aug 2026, 16:30
Abbott Reports Positive Phase 3-Style Clinical Data for TactiFlex Duo AFib Catheter
Abbott (NYSE: ABT) announced positive 12-month clinical results for its investigational TactiFlex Duo Ablation Catheter, a device designed to treat challenging cases of atrial fibrillation (AFib).
TactiFlex Duo combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single catheter, allowing physicians to select or combine ablation approaches depending on a patient’s needs. The technology works with Abbott’s EnSite X cardiac mapping system to provide real-time feedback during procedures.
In the FlexPulse Global IDE study, 92.6% of patients with paroxysmal AFib had no documented recurrence of AFib, atrial flutter or atrial tachycardia under standard-of-care monitoring. Under more rigorous protocol-driven monitoring, 77.4% remained free from documented recurrence.
The study also met its primary effectiveness endpoint, with 74.6% of patients remaining free from documented arrhythmias, medication changes or repeat procedures. Abbott reported a 98.3% safety rate with no major safety events.
The results are important for Abbott’s electrophysiology business as competition intensifies in the fast-growing PFA market. Combining PFA and traditional RF energy in one catheter could differentiate TactiFlex Duo by giving physicians greater flexibility when treating more complex arrhythmias.
The device received CE Mark in Europe earlier this year, while the FlexPulse IDE study is intended to support an application for U.S. FDA approval. The latest data were presented at the European Society of Cardiology Congress 2026 and published in EP Europace.
Abbott (NYSE: ABT) announced positive 12-month clinical results for its investigational TactiFlex Duo Ablation Catheter, a device designed to treat challenging cases of atrial fibrillation (AFib).
TactiFlex Duo combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single catheter, allowing physicians to select or combine ablation approaches depending on a patient’s needs. The technology works with Abbott’s EnSite X cardiac mapping system to provide real-time feedback during procedures.
In the FlexPulse Global IDE study, 92.6% of patients with paroxysmal AFib had no documented recurrence of AFib, atrial flutter or atrial tachycardia under standard-of-care monitoring. Under more rigorous protocol-driven monitoring, 77.4% remained free from documented recurrence.
The study also met its primary effectiveness endpoint, with 74.6% of patients remaining free from documented arrhythmias, medication changes or repeat procedures. Abbott reported a 98.3% safety rate with no major safety events.
The results are important for Abbott’s electrophysiology business as competition intensifies in the fast-growing PFA market. Combining PFA and traditional RF energy in one catheter could differentiate TactiFlex Duo by giving physicians greater flexibility when treating more complex arrhythmias.
The device received CE Mark in Europe earlier this year, while the FlexPulse IDE study is intended to support an application for U.S. FDA approval. The latest data were presented at the European Society of Cardiology Congress 2026 and published in EP Europace.
