Johnson & Johnson MedTech has paused the U.S. rollout of its Varipulse pulsed field ablation (PFA) system after four neurovascular events were reported during an external evaluation. The pause, which began on January 5, 2025, is intended to allow the company to investigate the cause of these events.
The Varipulse system received FDA approval in November 2024 for treating drug-refractory paroxysmal atrial fibrillation (AFib). It combines PFA with the Carto 3 mapping system for precise ablations. The external evaluation involved over 130 cases across 14 U.S. sites.
Investigation Details
J&J stated that the U.S. external evaluation used a unique platform configuration, meaning the pause does not affect Varipulse cases outside the U.S., where over 3,000 commercial cases have been completed. The company is working to complete the investigation and resume the U.S. evaluation, with more information expected in the coming days.
Analyst Perspectives
Needham analyst Mike Matson noted that concerns about stroke risk with Varipulse procedures had been raised previously, citing cerebrovascular events in the Admire pivotal study. Matson suggests electrophysiologists may become wary of using the device, potentially benefiting Boston Scientific and Medtronic. Citi Research analyst Joanne Wuensch believes the issue may not be the device itself but potentially an aspect of it.
Impact on the PFA Market
The pause comes shortly after J&J entered the U.S. PFA market, joining Boston Scientific and Medtronic. These companies have gained quick adoption due to perceived safety benefits over traditional cardiac ablation methods. Medtronic's PulseSelect PFA system was approved in December 2023, followed by Boston Scientific's Farapulse device in January 2024.
Expert Commentary
Sumit Verma, MD, noted that many centers were awaiting the Varipulse system, making the pause a setback for PFA adoption. Jonathan Piccini, MD, speculated that the neurovascular events could be related to issues seen in the inspIRE study, such as silent cerebral ischemic lesions. Dhanunjaya Lakkireddy, MD, suggested the events might be related to initial user experience with the catheter and workflow management.
