The US Food and Drug Administration (FDA) has approved Abbott's TactiFlex Duo Ablation Catheter, Sensor Enabled, for treating patients with atrial fibrillation (AFib), including complex cases.1
Announced by the company on September 8, 2026, the approval rests on 12-month results from the FlexPulse investigational device exemption (IDE) study, presented as late-breaking data at the European Society of Cardiology (ESC) Congress 2026 and published simultaneously in EP Europace. Abbott plans to expand commercial availability of the catheter across the United States in the coming weeks.1,2
“Electrophysiology is rapidly evolving as physicians adopt new technologies that improve the safety and effectiveness of AFib treatment,” Atul Verma, MD, director of cardiology at the McGill University Health Center in Montreal, said in a statement. “TactiFlex Duo provides physicians with greater flexibility during procedures, and when it is combined with the high-resolution 3D visualization available through Abbott’s EnSite X mapping system, physicians have a suite of practice-changing tools to confidently treat patients with complex AFib.”1
The approval gives US electrophysiologists a single catheter capable of delivering PFA, RF energy, or both within one procedure rather than requiring separate tools for each modality. Abbott markets the device for patients with complex anatomy or prior failed ablation, a population operators often manage with longer or staged procedures.1
The FlexPulse IDE study was a prospective, multicenter, single-arm, nonrandomized trial designed to support US approval of TactiFlex Duo. Investigators enrolled patients with symptomatic, recurrent, drug-refractory paroxysmal AFib between November 2024 and April 2025. Pulmonary vein isolation was achieved in all 180 study participants using the dual-energy catheter.2
At 12 months, the study met its primary effectiveness endpoint, with 74.6% of patients remaining free from documented arrhythmia recurrence, antiarrhythmic medication changes, or repeat ablation procedures. 2 secondary monitoring analyses reinforced the primary result: 92.6% of patients had no documented recurrence of AFib, atrial flutter, or atrial tachycardia under standard-of-care monitoring, while 77.4% remained recurrence-free under more intensive protocol-driven monitoring.2
TactiFlex Duo safety profile and EnSite X integration
The primary safety endpoint event rate in FlexPulse was 1.7%, and Abbott reported no major safety signals through twelve months of follow-up. The company also noted that the safety profile was consistent across sites and energy modalities used during the study.2
TactiFlex Duo integrates with Abbott's EnSite X EP System, which layers three-dimensional cardiac mapping with the PFA Index, a feature designed to give operators real-time feedback on lesion formation as pulsed field energy is delivered.1
Additional integration with the Advisor HD Grid X mapping catheter and the ViewFlex X intracardiac echocardiography catheter is intended to provide real-time catheter position and tissue-contact data during ablation. Abbott positions the combined mapping, imaging, and dual-energy ablation platform as suited to physicians managing anatomically complex AFib cases or procedures complicated by prior failed ablation.1
“TactiFlex Duo represents an important advancement as Abbott builds the industry’s most comprehensive electrophysiology portfolio,” Uri Yaron, senior vice president of electrophysiology at Abbott, said in a statement. “By continuing to expand our PFA portfolio and integrate innovative technologies across cardiovascular care, we're helping physicians navigate increasingly complex procedures while ensuring more patients receive the right care at the right time."1
Abbott said TactiFlex Duo extends a broader electrophysiology portfolio spanning diagnosis, mapping, intracardiac imaging, and ablation. The approval follows 2025 US and European clearances for the Volt PFA System and adds to a series of PFA-related approvals the company has secured across the United States, Europe, Asia, and Latin America over the past year.1
References
Hussein AA, Rackauskas G, Sundaram S, Piccini JP, Roithinger FX, Tung P, Osorio J, Colley BJ 3rd, Siddiqui UR, Lakkireddy DR, Chinitz LA, Hyman MC, Zitella Verbick L, Dirckx N, Woods V, Lo M; and the FlexPulse Investigators. Safety and Effectiveness of a Novel Dual-Energy Radiofrequency/Pulsed Field Ablation Catheter: 12 Month Results of the FlexPulse Study. Europace. 2026 Aug 29:euag238. doi: 10.1093/europace/euag238. Epub ahead of print. PMID: 42667242.
