The TactiFlex Duo combines pulsed field ablation and radiofrequency energy in a single catheter for treating patients with atrial fibrillation.
The US Food and Drug Administration has cleared the TactiFlex Duo Ablation Catheter, Sensor Enabled, to treat patients with challenging cases of atrial fibrillation, Abbott announced in a company release.
According to Abbott, the dual-energy device combines pulsed field ablation and radiofrequency energy in a single catheter, allowing clinicians to tailor treatment to each patient’s individual needs. The company plans to begin cases with broader commercial rollout across the US in the coming weeks.
According to the company release, approximately 10.5 million people in the US live with atrial fibrillation, an irregular heart rhythm that increases the risk of severe complications, including stroke. While medications manage the condition for some patients, others require cardiac ablation, a minimally invasive procedure that creates small areas of scar tissue to disrupt faulty electrical pathways in the heart and restore a normal heartbeat.
“Electrophysiology is rapidly evolving as physicians adopt new technologies that improve the safety and effectiveness of AFib treatment,” says Atul Verma, MD, director of cardiology at the McGill University Health Centre in Montreal, Canada, in a release. “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.”
Mapping Integration and Clinical Evidence
According to Abbott, the catheter is integrated with the company’s EnSite X electrophysiology system, which constructs three-dimensional cardiac maps to help clinicians identify and target abnormal electrical signals. The mapping platform includes the pulsed field ablation index, a tool that provides real-time guidance to evaluate lesion formation while helping minimize impact to surrounding healthy tissue, the company stated.
The catheter also functions alongside Abbott’s Advisor HD Grid X mapping catheter, ViewFlex X intracardiac echocardiography catheter, and EnSite Echo Module to provide real-time visualization of catheter positioning and heart structures throughout an intervention.
Abbott stated that the regulatory approval was supported by results from the FlexPulse clinical study. Late-breaking data presented at the European Society of Cardiology Congress 2026 and published in EP Europace demonstrated favorable safety and effectiveness rates in patients treated for paroxysmal atrial fibrillation, according to the manufacturer.
Portfolio Expansion
The clearance marks Abbott’s fifth major regulatory milestone in electrophysiology in just over a year, the company noted. Previous milestones include European CE Mark approvals for the Amulet 360 and TactiFlex Duo, alongside US and European approvals for the Volt pulsed field ablation system in 2025.
“TactiFlex Duo represents an important advancement as Abbott builds the industry’s most comprehensive electrophysiology portfolio,” says Uri Yaron, senior vice president of Abbott’s electrophysiology business, in a release. “From diagnosis, mapping and intracardiac ultrasound imaging to advanced treatments for the most complex arrhythmias, Abbott is uniquely positioned to support physicians at every stage of patient care. By continuing to expand our [paroxysmal atrial fibrillation] 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.”
