Abbott said the FDA has approved its TactiFlex Duo Ablation Catheter to treat patients with challenging cases of atrial fibrillation (AFib). The company said it will begin cases with broader commercial adoption across the country in the coming weeks.
TactiFlex Duo allows physicians to use pulsed field ablation (PFA), radiofrequency (RF) energy, or a combination of both during a procedure. Abbott's EnSite X EP System also provides physicians with real-time feedback as an integrated mapping solution with the PFA Index (PI), a tool designed to assess lesion formation during ablation with TactiFlex Duo. The dual-energy approach means physicians can create precise therapeutic lesions, or small areas of scar tissue, that block the abnormal electrical signals causing an irregular heartbeat while helping minimize the impact on surrounding healthy tissue.
The FDA approval of TactiFlex Duo further expands Abbott's portfolio of technologies designed to help physicians treat patients with cardiac arrhythmias. It is the company's fifth major electrophysiology approval in just over a year, following Europe's Amulet 360 and TactiFlex Duo CE Mark approvals this year, and U.S. and European approvals of the Volt PFA System in 2025.
