Abbott Park, Illinois, U.S., September 8, 2026
Abbott has received U.S. FDA approval for its TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, a dual-energy cardiac ablation device designed to treat patients with challenging cases of atrial fibrillation (AFib). The catheter combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single device, giving physicians greater flexibility during cardiac ablation procedures. The regulatory milestone expands Abbott’s growing electrophysiology portfolio and follows clinical evidence demonstrating favorable safety and effectiveness in patients undergoing treatment for abnormal heart rhythms.
Abbott’s TactiFlex Duo Combines Two Ablation Energies
TactiFlex Duo is designed to provide physicians with multiple energy options during an AFib ablation procedure. The catheter can deliver PFA, RF energy or a combination of both, allowing clinicians to adapt treatment according to patient anatomy and procedural requirements. This flexibility may be particularly relevant for patients with complex anatomy, prior ablation procedures or challenging clinical situations. Cardiac ablation is a minimally invasive procedure used to target areas of heart tissue responsible for abnormal electrical signals. By creating precisely positioned therapeutic lesions, physicians aim to interrupt the electrical pathways that contribute to irregular heart rhythms and restore more normal cardiac rhythm. The dual-energy design represents an evolution in electrophysiology technology, where PFA and RF ablation can be incorporated into one treatment platform rather than requiring physicians to rely on separate catheter technologies. Abbott said the device is intended to provide greater procedural flexibility while supporting precision during complex AFib interventions.
Clinical Evidence Supports FDA Approval
The FDA approval was supported by results from Abbott’s FlexPulse IDE clinical study, which evaluated the safety and effectiveness of TactiFlex Duo in patients with paroxysmal atrial fibrillation. Late-breaking results from the study were recently presented at the European Society of Cardiology (ESC) Congress 2026 and simultaneously published in EP Europace. The clinical evidence contributed to the regulatory evaluation of the device and demonstrated favorable outcomes for patients undergoing AFib treatment. The FDA authorization represents an important transition from clinical investigation to broader commercial use in the United States, with Abbott expecting broader adoption of the technology in the coming weeks. An important feature of the TactiFlex Duo ecosystem is its integration with Abbott’s EnSite™ X EP System, a cardiac mapping platform that provides detailed three-dimensional visualization of the heart. The system incorporates a PFA Index, which is designed to provide real-time information about lesion formation during pulsed field ablation. The broader technology platform can also integrate with Abbott’s Advisor™ HD Grid X mapping catheter and ViewFlex™ X ICE catheter, supporting visualization, mapping and procedural guidance. These technologies are designed to provide physicians with real-time information about catheter position and movement while creating a digital representation of the patient’s cardiac anatomy.
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Abbott Expands Its Cardiac Electrophysiology Portfolio
The TactiFlex Duo approval adds another major regulatory milestone to Abbott’s rapidly expanding pulsed field ablation portfolio. The company said this represents its fifth major electrophysiology approval in just over a year, following additional regulatory milestones for its cardiac rhythm technologies in the United States, Europe and other international markets. The expansion comes as AFib treatment technology continues to evolve, with physicians seeking approaches that can provide effective lesion creation while improving procedural flexibility and minimizing unintended effects on surrounding tissue. Abbott’s strategy combines ablation, mapping, imaging and navigation technologies into an integrated electrophysiology ecosystem. For patients, the availability of TactiFlex Duo provides another FDA-approved option for the treatment of challenging AFib cases. For physicians, the ability to use PFA and RF energy through one catheter could offer greater flexibility when tailoring ablation procedures. The FDA approval therefore represents both a regulatory and technological milestone for Abbott, strengthening its position in cardiac electrophysiology and expanding access to dual-energy ablation technology for patients with abnormal heart rhythms.
Source: Abbott press release
