J&J MedTech Pauses Varipulse PFA Cases Over Neurovascular Events

Johnson & Johnson MedTech has temporarily paused the U.S. external evaluation of its Varipulse cases while the company investigates the root cause of four reported neurovascular events in the evaluation.

The pause began on January 5, 2024.

“As the U.S. External Evaluation leveraged a unique platform configuration, there is no impact to commercial activity and VARIPULSE cases outside of the U.S.,” the company advised in a press release.

Varipulse enables AFib treatment with one device that combines pulsed field ablation (PFA) therapy and advanced mapping with the CARTO 3 system, a 3D electroanatomical cardiac mapping system. According to J&J, VARIPULSE’s precise energy delivery and real-time catheter position visualization with CARTO 3 enable safety and accuracy in ablation procedures.

The Varipulse PFA system earned U.S. Food and Drug Administration (FDA) approval to treat drug refractory, paroxysmal atrial fibrillation (AFib) in November 2024.

The company said it had completed more than 130 cases using Varipulse as of January 3, 2025. Over 3,000 commercial cases were completed across the world.

We are working diligently to complete the investigation according to our medical safety processes and resume the U.S. External Evaluation,” J&J MedTech said. “We expect to have more information to communicate within the coming days.”