Abbott Receives FDA Approval for Device to Treat Abnormal Heart Rhythm

By Connor Hart

Abbott Laboratories said it received FDA approval for its TactiFlex Duo Ablation catheter as a treatment for people with abnormal heart rhythms.

The healthcare company said Tuesday that the U.S. approval of the catheter marks a significant milestone in its commitment to advancing therapies that help physicians treat complex heart rhythms.

The approval marks Abbott's fifth major electrophysiology approval in just over a year, the company said.

Abbott said its latest approval from the U.S. Food and Drug Administration was based on results from a recent study, in which the TactiFlex device showed favorable safety and effectiveness outcomes in patients with atrial fibrillation. Afib, as the condition is also known, refers to an abnormal heart rhythm.

The dual-energy catheter allows physicians to use pulsed field ablation, radiofrequency energy, or a combination of both during a cardiac ablation procedure, helping them to tailor treatment to each patient's needs, the company said.

"TactiFlex Duo represents an important advancement as Abbott builds the industry's most comprehensive electrophysiology portfolio," said Uri Yaron, senior vice president of Abbott's electrophysiology business.

"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," he added.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

September 08, 2026 09:25 ET (13:25 GMT)