J&J Halts PFA Cases Amid Stroke ReportsJ&J Halts PFA Cases Amid Stroke Reports

Johnson & Johnson hit the pause button on the U.S. external evaluation and all U.S. Varipulse cases as the New Brunswick, NJ-based company investigates the cause of four reported neurovascular events.

As the U.S. external evaluation leveraged a unique platform configuration, J&J said, there is no impact on commercial activity and Varipulse pulsed field ablation (PFA) cases outside of the United States. Since beginning the external evaluation cases with the platform in the United States, the company said it has completed more than 130 cases across 14 sites and 40 operators as of January 3.

"We are working diligently to complete the investigation according to our medical safety processes and resume the U.S. external evaluation," the company said in a statement. "We expect to have more information to communicate within the coming days."

According to an adverse event report in FDA's Manufacturer and User Facility Device Experience (MAUDE) database, a patient had a stroke shortly after ablation using the Varipulse platform during a U.S. clinical trial in September 2024, before FDA approval. Before this event, according to the report, at least two patients had post-procedural strokes after ablation using the platform in Europe.

FDA approved the Varipulse system in November 2024. Boston Scientific and Medtronic both have pulsed field ablation systems on the U.S. market as well.

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"It is unclear how long the Varipulse sales will remain paused, but even if [J&J] allows sales to be resumed, we believe that the product is now likely to be tainted and that electrophysiologists are likely to be wary of using it," Mike Matson, a medtech analyst at Needham & Co., wrote in a report Wednesday. "We believe that this will clearly benefit both [Boston Scientific] and Medtronic ... assuming that their products don't have similar issues."

The analyst added that he believes Boston Scientific's Farapulse is largely proven at this point given the large number of real-world procedures and no indications to date of elevated stroke rates.

In J&J's pivotal admIRE study, there were three patients of the 277 total patients (1.1%) that had cerebrovascular events (two strokes and one transient ischemic attack).

In September 2024, Komandoor Srivathsan, MD (Mayo Clinic, Phoenix, AZ), told TCTMD he had concerns about the cerebrovascular events reported in the admIRE study and that he did not believe the issue was related to a lack of familiarity with sheath management because the study was performed at experienced centers with seasoned operators. Srivathsan suggested to the publication that the adverse events could have to do with the Varipulse catheter's PFA waveform, a feature that differs between various technologies and remains proprietary to each manufacturer.

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