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

After more than a monthlong pause in response to four neurovascular events linked to its Varipulse pulsed-field ablation system, Johnson & Johnson announced late last week that it will resume use of the device in a limited market release in the United States.

Cases were stopped  “out of an abundance of caution” on January 5 to allow time for an investigation into why these neurovascular events were observed during the company’s US External Evaluation study. There were no deaths related to these events, according to a J&J spokesperson.

The investigation found that the “devices operate as intended” and there was no difference in the performance of the available Varipulse systems used globally, according to Johnson & Johnson.

However, the investigation “found the risk of neurovascular events may increase if a high number of ablations, the stacking of ablations, and/or ablations outside of the pulmonary veins are delivered.”

The company said it will update the instructions for use to provide enhanced guidance for operators and continue to educate users about recommended practices.

“Comprehensive patient selection, procedural patient management, and guidance on pulmonary vein isolation (PVI) ablation workflows have always been fundamental to our Varipulse training program to reduce the risk of complications,” the spokesperson said.

The Varipulse system, which is equipped with an integrated electroanatomical mapping system, was approved by the US Food and Drug Administration in November 2024 with support by the positive results of the pivotal admIRE trial in patients with drug-refractory, symptomatic paroxysmal atrial fibrillation. One commentator noted at the time of publication, however, that the occurrence of two strokes and one TIA in that study was “somewhat worrisome.”