Johnson & Johnson MedTech Pauses United States External Evaluation of Varipulse

January 8, 2025—Johnson & Johnson MedTech announced that it has temporarily paused the United States External Evaluation and all United States Varipulse cases while the company investigates the root cause of four reported neurovascular events in the United States External Evaluation.

The pause took effect January 5 and has been instituted out of an abundance of caution, stated the company.

Johnson & Johnson MedTech stated that it is working diligently to complete the investigation according to its medical safety processes and resume the United States External Evaluation. The company expects that more information will be communicated within the coming days.

The company advised there is no impact on commercial activity and Varipulse cases outside of the United States because the United States External Evaluation leveraged a unique platform configuration.

As of January 3, 2025, more than 130 cases across 14 sites and 40 operators have been completed in the External Evaluation cases with the Varipulse platform in the United States. Globally, the Varipulse rollout has been successful, with more than 3,000 commercial cases completed, noted Johnson & Johnson MedTech.

On November 7, 2024, Johnson & Johnson MedTech announced FDA approval of the Varipulse platform for treating drug-refractory paroxysmal atrial fibrillation.