HQ Team
January 10, 2025: Johnson & Johnson paused its rollout of a heart device to treat atrial fibrillation “out of an abundance of caution,” as it probes three cases of neurovascular events related to the device.
One of the patients had a stroke shortly after an ablation while using the Varipulse platform during a clinical trial in the US, before the Food and Drug Administration’s approval in November 2024, according to a statement from Biosense Webster Inc., an arm of J&J.
The regulator, FDA, conducts external evaluations of products and applications to ensure public health safety. The FDA regulates several products, including drugs, medical devices, food, and cosmetics.
This process requires clinical trials and other data to demonstrate the device’s safety and effectiveness.
Stroke, ischemia
That adverse event was reported to the Food and Drug Administration, according to the statement filed to the Manufacturer and User Facility Device Experience by Biosense.
“Before this event, at least two patients had a similar complication (postprocedural stroke) using the Varipulse platform in Europe (commercial release).
“These events might be related, it is unclear if they were reported to the FDA.”
The decision to pause the US External Evaluation was taken on January 5 after the study of 277 patients when the three adverse events — two strokes and one transient ischemic attack —occurred.
No impact outside of US
Since the beginning of the cases with the Veripulse platform in the US, the company said it has completed more than 130 cases across 14 sites and 40 operators as of January 3, according to a company statement.
As the US External Evaluation leveraged a unique platform configuration, “there is no impact to commercial activity and Varipulse cases outside of the US.”
“Globally, the Varipulse rollout has been successful, with over 3,000 commercial cases completed. We are working diligently to complete the investigation according to our medical safety processes and resume the US External Evaluation.”
Atrial fibrillation
Johnson & Johnson’s Varipulse pulsed-field ablation (PFA) system treats drug-resistant paroxysmal atrial fibrillation (AFib) — a common form of abnormal rhythm in the heart’s upper chambers that affects millions of people in the US, Europe, and Japan.
The single device combines PFA therapy and the CARTO 3 electroanatomical mapping system. The Varipulse system is designed to help electrophysiologists view the inside of the heart to position the catheter.
Boston Scientific and Medtronic are the other companies that sell pulsed field ablation systems on the US market.
