Following a temporary, voluntary pause of US external evaluation and all US cases with its Varipulse catheter, Johnson & Johnson (J&J) is set to resume the limited market release of these devices in the USA in light of a comprehensive investigation that found they operate as intended.
J&J will update the instructions for use (IFU) globally for the Varipulse catheter to include enhanced guidance, as stated in a recent press release.
An earlier release—dated 5 January—noted that, “out of an abundance of caution”, J&J had temporarily paused all US Varipulse cases and US external evaluation of the device while the company investigated the root cause of four reported neurovascular events in the external evaluation. J&J claimed that, as the US external evaluation leveraged a unique platform configuration, there would be no impact to commercial activity nor Varipulse cases outside of the USA.
The earlier release also highlighted the fact that, since beginning external evaluation cases with the Varipulse platform in the USA, J&J had completed more than 130 cases across 14 sites and 40 operators (as of 3 January 2025), while the successful global rollout of Varipulse had seen over 3,000 commercial cases completed.
An investigation into potential device-, procedure- and patient-related factors subsequently concluded that Varipulse devices operate as intended and there is no difference across the performance of the available Varipulse system configurations globally.
The investigation found that the risk of neurovascular events may increase if a high number of ablations, the stacking of ablations, and/or ablations outside of the pulmonary veins, are delivered, according to J&J.
The company is communicating with healthcare professionals using Varipulse to recommend that they review and adhere to the updated IFU, and share information with patients.
“We will continue to educate healthcare professionals with guidance around recommended practices aligned to our clinical studies,” J&J’s recent release notes.
The release describes Varipulse as an important treatment option for patients with atrial fibrillation (AF) that remains available in all markets where commercially launched.
