Johnson & Johnson Pauses Use of FDA-Approved PFA System to Investigate Patient Complications

Johnson & Johnson MedTech has temporarily suspended use of its Varipulse Pulsed Field Ablation (PFA) system in the United States after it was linked to four “neurovascular events” in patients undergoing treatment.

The company did not provide any further information about the events in question. Although the FDA’s Manufacturer and User Facility Device Experience Database contains a report of a patient who suffered a stroke after treatment with Varipulse, the report dates back to September 2024.

The news follows FDA approval in 2024

Johnson & Johnson MedTech first received FDA approval for the Varipulse PFA system in November 2024. The agency previously approved Medtronic’s PulseSelect and Affera systems and Boston Scientific’s Farapulse system.

The FDA made its decision after reviewing data from the admIRE clinical trial, which included 277 patients across the United States who underwent treatment with the Varipulse System. The study associated PFA with Varipulse with acute procedural success in 100% of patients and a primary efficacy success rate of 75%. Adverse events occurred in only 2.9% of patients and 43% were able to go home on the day of treatment.