J&J Halts Varipulse Pulsed-Field Ablation Cases in the US

All ablation cases set to use the Varipulse pulsed-field ablation (PFA) system have been temporarily halted in the United States after four neurovascular events were reported during an external evaluation, device maker Johnson & Johnson Medtech announced Wednesday.

The pause, which was initiated Sunday “out of an abundance of caution,” will allow the manufacturer time to investigate the root cause of the complications.

Johnson & Johnson Medtech noted that because system used in the US External Evaluation study “leveraged a unique platform configuration, there is no impact to commercial activity and Varipulse cases outside of the US.”

The move is a setback for US rollout following Food and Drug Administration approval for Varipulse, which comes with an integrated electroanatomical mapping system, in November 2024. That was supported by the positive results of the pivotal admIRE trial in patients with drug-refractory, symptomatic paroxysmal atrial fibrillation, although the occurrence of two strokes and one TIA in that study was called “somewhat worrisome” by a commentator at the time.

External evaluation of Varipulse in the US—which is “a limited rollout intended to collect physician feedback on a new technology before broader full release,” according to a J&J spokesperson—has included, as of January 3, 2025, more than 130 cases performed across 14 sites by 40 operators.

“Globally, the Varipulse rollout has been successful, with over 3,000 commercial cases completed,” the Johnson & Johnson Medtech said, adding that it is “working diligently to complete the investigation according to our medical safety processes and resume the US External Evaluation.”