Johnson & Johnson MedTech said it has temporarily paused the U.S. External Evaluation and all U.S. VARIPULSE cases while the company investigates the root cause of four reported neurovascular events.
The VARIPULSE Platform is designed to enable AFib treatment with a single device that combines pulsed field ablation (PFA) therapy and advanced mapping with the CARTO 3 System, a 3D electroanatomical cardiac mapping system. J&J said that since 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.
"Since beginning the External Evaluation cases with the VARIPULSE Platform in the U.S., we have completed more than 130 cases across 14 sites and 40 operators. Globally, the VARIPULSE rollout has been successful, with over 3,000 commercial cases completed," the company said in a statement. "We are working diligently to complete the investigation according to our medical safety processes and resume the U.S. External Evaluation. We expect to have more information to communicate within the coming days."
J&J MedTech in November announced FDA approval for VARIPULSE, which is designed for a minimal- to zero-fluoro workflow through integration with the intracardiac echocardiography (ICE) ultrasound portfolio.
