Abbott Receives FDA Approval for Tactiflex™ Ablation Catheter

Saturday, May 20, 2023

Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the TactiFlex™ Ablation Catheter, Sensor Enabled™, the world's first ablation catheter with a flexible tip and contact force technology.

Unlike other catheters on the market, the TactiFlex catheter uses a tip design with a laser-cut pattern that flexes when in contact with the heart wall. This helps direct fluid to the treated tissue1 and allows for more accurate positioning of the catheter – providing up to two-times higher stability in a beating heart – for consistent therapy delivery.

The TactiFlex catheter is designed to be used with EnSite X EP System, an industry-leading heart mapping system, which allows physicians to view and precisely identify areas in the heart that require ablation.

The TactiFlex catheter generated strong clinical outcomes in the TactiFlex AF IDE study. It is also approved for use in Europe, Japan, Africa and Australia.

More than 37 million people worldwide live with atrial fibrillation (AFib) and numbers are predicted to more than double by 2050. With the introduction of new tool such as TactiFlex, when used with mapping systems to accurately identify the source of an arrhythmia, can safely and efficiently treat the problem in ways that never thought possible a decade ago.