FDA approves new Abbott catheter capable of PFA and radiofrequency ablation
Abbott has received U.S. Food and Drug Administration (FDA) approval for its TactiFlex Duo Ablation Catheter, Sensor Enabled to be used for the treatment of patients with abnormal heart rhythms.
The device was designed to deliver both pulsed field ablation (PFA) energy and radiofrequency energy, providing care teams with multiple treatment options during cardiac ablation procedures. PFA, a major trend electrophysiology, uses high-energy electrical pulses to target the cells responsible for abnormal heart rhythms. Radiofrequency, meanwhile, has been around much longer and relies on the use of heat. This newly approved device allows users to switch back and forth from one ablation type to the other—or use a combination of the two techniques—as necessary when targeting complex atrial fibrillation (AFib) cases.
In addition, Abbott noted, its EnSite X EP System offers users real-time feedback as they perform ablation procedures.
“TactiFlex Duo represents an important advancement as Abbott builds the industry's most comprehensive electrophysiology portfolio,” Uri Yaron, senior vice president of Abbott's electrophysiology business, said in a statement. “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 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.”
“Electrophysiology is rapidly evolving as physicians adopt new technologies that improve the safety and effectiveness of AFib treatment,” added Atul Verma, MD, director of cardiology at the McGill University Health Centre in Montreal, Canada. “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.”
Findings from the FLEXPULSE IDE trial were just presented at ESC Congress 2026 and simultaneously published in EP Europace.[1] According to that study, which included 180 patients with symptomatic AFib, treatment with the TactiFlex Duo Ablation Catheter, Sensor Enabled was “safe and effective.”
Back in January, Abbott received CE mark approval for the TactiFlex Duo Ablation Catheter, Sensor Enabled. This FDA approval continues that momentum.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.