Johnson & Johnson has won U.S. Food and Drug Administration approval for a catheter that delivers both radiofrequency and pulsed field energy to treat atrial fibrillation. The company expects physicians to perform the first procedures with the device this summer as it starts a phased commercial rollout.
The approval covers the Dual Energy Thermocool Smarttouch SF Platform, which J&J disclosed Wednesday. It already had approval for a single-energy radiofrequency version of the same device. The new catheter is integrated into the company’s Carto mapping system.
How J&J plans to catch up in the PFA market
Boston Scientific and Medtronic beat the company to the pulsed field ablation, or PFA, market. Shortly after it launched its Varipulse PFA device, the firm temporarily paused all U.S. cases to investigate four reported neurovascular events. That pause created an opening for rivals.
As 2026 began, Joaquin Duato, the company’s CEO, said it was “gaining back share in PFA” and predicted it would launch “a new catheter every year through the end of the decade.” The dual-energy catheter is central to that strategy.
The logic behind offering both energy types in one catheter is straightforward.
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Not all atrial fibrillation cases are the same. Physicians often need to switch between radiofrequency and pulsed field energy depending on what they encounter in a patient’s anatomy. Having a single device that handles both simplifies the procedure and reduces the need to swap catheters mid-surgery.
What physicians and analysts are saying
The company received a CE mark for the dual-energy Thermocool catheter in January 2025 and began its first cases in Europe later that year. Duato said on the company’s first-quarter earnings call in April that it continues “to receive strong feedback” for the device in Europe.
Talking to the firm’s Michael Bodner at an event in May, RBC Capital Markets analyst Shagun Singh said her channel checks indicated that dual-energy catheters are used in about 20% to 30% of cases. The device could help the firm “regain more share in the complicated end of the procedure spectrum,” Singh said, citing key opinion leaders.
Bodner, company group chair of electrophysiology and neurovascular at the firm, noted the dual-energy device is based on the most widely used radiofrequency catheter globally. Physicians train on that catheter and are most familiar with it, he said. Adding the ability to toggle between radiofrequency and pulsed field energy gives physicians “a lot of versatility, depending on the complexity of the patient,” Bodner explained. He outlined how ablations near anatomy such as the coronary arteries pose challenges that make access to different energy valuable.