Abbott wins FDA approval for AFib catheter

• Abbott received U.S. FDA approval for TactiFlex Duo Ablation Catheter, Sensor Enabled, a device combining pulsed field ablation and radiofrequency energy for atrial fibrillation treatment.
• The catheter expands Abbott’s electrophysiology portfolio and will support U.S. procedures beginning in the coming weeks.
• The device is designed to allow physicians to select PFA, RF energy, or both during AFib procedures using Abbott’s cardiac mapping system.

Abbott (NYSE:ABT) received U.S. FDA approval for its TactiFlex Duo Ablation Catheter, Sensor Enabled, a device designed to treat atrial fibrillation using pulsed field ablation and radiofrequency energy technologies.

The catheter combines two ablation methods in one device, allowing physicians to use either energy source or both during procedures to create targeted cardiac lesions.

The FDA approval was supported by safety and effectiveness data from the FlexPulse IDE study in patients with paroxysmal atrial fibrillation, and the device works with Abbott’s EnSite X EP System for 3D cardiac mapping.

Abbott said TactiFlex Duo includes a PFA Index tool that helps physicians evaluate lesion formation in real time, and the company expects U.S. procedures to begin in the coming weeks.

Abbott develops medical devices across cardiovascular, diagnostics, diabetes care, and other healthcare areas, with electrophysiology products forming part of its cardiovascular technology portfolio.