Biosense Webster Advisory: Update to the Instructions for Use for VARIPULSE

Biosense Webster, Inc. (BWI) is now re-contacting users of the VARIPULSE™ Platform (including the VARIPULSE™ Bi-Directional Ablation Catheter) to share important updates on the device’s Instructions for Use (IFU). In January 2025, there was a pause in the U.S. External Evaluation (early launch) phase of the commercial release of VARIPULSE™ due to four (4) neurovascular events (strokes) being reported after the use of their system. It was noted that there was a greater than anticipated peri-procedural event rate (3% [4 cases in 132] versus 1.1% seen in the U.S. pre-market study).

During the pause, BWI investigated potential device-, procedure-, and patient-related factors that may have contributed to the higher event rate. Based on their evaluation, BWI did not identify a single direct causal relationship to explain the increased rate of stroke. According to BWI, the devices perform as intended, and there are no differences in performance among the available VARIPULSE™ system configurations worldwide.

However, their analysis did suggest that certain technical and patient factors may lead to a greater risk of neurovascular events and should be considered when using the system.  All four (4) patients with stroke had ablation performed beyond the pulmonary veins, and 3 of 4 had persistent atrial fibrillation.  BWI reiterates that the VARIPULSE™ system is FDA-labeled for paroxysmal AF. Specific workflows, such as “stacking” or a high number of ablations, or patient conditions such as low blood flow (i.e. persistent AF), may contribute to joule heating that could increase the likelihood of char (three of the four events reported char formation on the electrodes). Ablation stacking occurs when at least five electrodes are placed within a 3 mm distance of one another during consecutive complete ablations.