Johnson & Johnson MedTech announced that it has resumed the limited market release of the Varipulse pulsed field ablation (PFA) system in the U.S. after a comprehensive investigation.

This comes after a voluntary pause last month due to reports of four reported neurovascular events in the evaluation. J&J said that the devices were found to operate as intended, and will update the Instructions for Use (IFU) globally for the Varipulse catheter to include enhanced guidance.

J&J said the investigation into possible device-, procedure-, and patient-related factors also concluded no difference in performance of available Varipulse system configurations across the world.

“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 told the press.

J&J said it’s communicating with clinicians using Varipulse to recommend they review and adhere to the updated IFU and share info with patients. The company is continuing to educate healthcare professionals with guidance around recommended practices aligned to its clinical studies.

The Varipulse PFA system earned U.S. Food and Drug Administration (FDA) approval to treat drug refractory, paroxysmal atrial fibrillation (AFib) in November 2024. It’s a treatment option for patients with atrial fibrillation (AFib) and remains available in all markets where it’s commercially launched.