The US Food and Drug Administration approved Abbott’s TactiFlex Duo Ablation Catheter, Sensor Enabled, for patients with challenging cases of atrial fibrillation, according to an Abbott press release.
TactiFlex Duo is designed to provide physicians with a choice of energy modalities during atrial fibrillation (AFib) ablation. The catheter can deliver pulsed field ablation or radiofrequency energy individually or in combination.
The catheter integrates with Abbott’s EnSite X EP system, which creates 3-dimensional maps of the heart and provides real-time information during ablation procedures. The EnSite X EP System also uses a PFA Index that provides information on lesion development during TactiFlex Duo ablation.
The press release reported favorable safety and effectiveness outcomes from the study in patients with paroxysmal AFib, characterized by episodes of irregular heart rhythm that come and go. Results were presented at the European Society of Cardiology Congress 2026 and simultaneously published in EP Europace.
“Electrophysiology is rapidly evolving as physicians adopt new technologies that improve the safety and effectiveness of AFib treatment,” said Atul Verma, MD, director of cardiology at the McGill University Health Centre in Montreal, Canada.
Abbott said cases with TactiFlex Duo would begin soon, with broader US commercial adoption planned in the coming weeks. The US authorization followed a CE Mark approval for TactiFlex Duo in Europe in 2026.
Source: Abbott
