Johnson & Johnson Temporarily Halts U.S. Use of FDA-Approved Varipulse PFA System Following Neurovascular Complications

Johnson & Johnson Medical Technologies has temporarily suspended the use of its Varipulse Pulse Field Ablation (PFA) system in the United States, following four "neurovascular events" associated with patients treated using the system.

FDA'sManufacturer and User Facility Device Experience DatabaseIncluding a report on a patient who suffered a stroke after receiving Varipulse treatment, but the report can be traced back to September 2024.

News After FDA Approval in 2024

Johnson & Johnson Medical Technologies received FDA approval for the Varipulse PFA system for the first timeNovember 2024. The agency had previously approved Medtronic's PulseSelect and Affera systems, as well as Boston Scientific's Farapulse system.

FDA in reviewingadmIRE Clinical TrialThe decision was made based on the data from the trial, which included 277 patients treated with the Varipulse system across the United States. The study linked PFA with Varipulse to 100% acute procedural success and a 75% primary effectiveness success rate. Only 2.9% of patients experienced adverse events, and 43% were able to go home on the same day as their treatment.

Johnson & Johnson Medical Technologies indeed pointed out that its external evaluation of Varipulse in the United States included 130 patients treated across 14 different sites before it was temporarily suspended. Globally, more than 3,000 commercial ablation procedures using the Varipulse system have been completed.

The company stated in aStatement"It said in a statement: 'We are working to complete our investigation according to our medical safety procedures and resume external assessments in the U.S.' 'We expect to have more information to communicate in the coming days.'"

The company emphasized,Due to the "unique platform configuration" used to evaluate U.S. cases, this temporary pause will not affect Varipulse cases being reviewed outside the United States.