J&J Pauses Varipulse PFA Rollout in U.S. Following Reported Neurovascular Events

Johnson & Johnson announced a pause in the U.S. external evaluation of its Varipulse PFA system for atrial fibrillation after four neurovascular events were reported. The temporary halt, initiated on January 5, affects only the limited U.S. rollout and not the international deployment, where over 3,000 commercial cases have been completed. The external evaluation aimed to collect physician feedback before a full-scale launch. Despite FDA approval in November 2024, concerns surrounding cerebrovascular events were flagged earlier in J&J’s pivotal Admire trial, where three out of 277 patients experienced similar complications.

This pause puts J&J’s Varipulse at a disadvantage against competitors like Boston Scientific’s Farapulse and Medtronic’s PulseSelect and Affera systems, which are already gaining traction due to their perceived safety advantages. Analysts are divided on the potential fallout, with some suggesting the events may not indicate a device flaw but rather an operational or procedural aspect requiring further assessment. While J&J works to complete its investigation and resume U.S. evaluations, competitors may capitalize on heightened concerns and hesitancy among electrophysiologists.