Johnson & Johnson MedTech is restarting the U.S. rollout of its Varipulse pulsed field ablation system after it paused procedures in early January following reports of four strokes among treated patients.
The company said its investigation uncovered no immediate device- or procedure-related factors, and that the system operates as intended to treat atrial fibrillation—however, it did report that the risk of neurovascular complications can escalate if a high number of ablations are delivered, or if ablations are stacked on top of one another to create deeper lesions within the cardiac tissue.
J&J also said the risk can increase if ablations are performed outside of isolating the pulmonary veins.
In response, the company said it plans to update Varipulse’s global instructions for use, and that it will work to educate healthcare professionals on its guidance and recommended practices.
During its interval in the U.S., the device continued to be employed elsewhere in the world to treat irregular heartbeat, and J&J said it found no differences in performance among Varipulse’s international configurations.
On Jan. 8, in its announcement of the pause, the company reported that more than 3,000 commercial cases had been completed globally, following regulatory green lights last year in the EU and Japan.
The FDA approved the Varipulse system in November 2024, after which the device moved into a limited market release and an external evaluation period. U.S. cases were paused Jan. 5, though more than 130 procedures were already performed across the country.
The move puts J&J back into competition with established pulsed field ablation developers Medtronic and Boston Scientific—the latter recently reporting that it had collected over $1 billion in revenue during the debut year of its Farapulse system, with more than 200,000 patients treated.
Meanwhile, Medtronic said this week it recently received FDA approval for a new manufacturing site in Ireland to boost the supply of its Affera platform, one of two pulsed field catheters from the company that have pushed its quarterly ablation sales up more than 20% year over year.