Johnson & Johnson is set to resume the limited market release of the Varipulse Catheter, a treatment option for atrial fibrillation (AFib), in the US.
The temporary suspension of the device’s US rollout began on 5 January 2025, following reports of four stroke events. This suspension affected the US External Evaluation and all Varipulse cases in the country.
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However, the latest decision to resume the market release follows a comprehensive investigation that confirmed the device’s function as intended.
The investigation, which looked into device, procedure, and patient-related factors, concluded that there is no difference in the performance of the Varipulse system configurations available worldwide.
However, it was found that the risk of neurovascular events may increase with a high number of ablations, stacking of ablations, or ablations performed outside of the pulmonary veins.
In a press statement, Johnson & Johnson said: “We will continue to educate healthcare professionals with guidance around recommended practices aligned to our clinical studies.”
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By GlobalDataThe device will be available in all markets where it is launched commercially.
The company also plans to update Varipulse’s instructions for use to provide enhanced guidance.
Healthcare providers are required to examine and comply with the revised IFU and share this information with patients.
The system, which integrates pulsed field ablation (PFA) therapy with advanced mapping capabilities, is designed to deliver precise ablations to increase safety.
The catheter’s full integration is expected to minimise the need for multiple visualisation methods used in a single procedure, thereby creating a streamlined workflow.
In November 2024, it received approval from the US Food and Drug Administration for the treatment of drug-refractory paroxysmal AFib.
