Biosense Webster Varipulse Ablation Catheter: Updated Usage Instructions and Stroke Risk

In late February, Biosense Webster updated the usage instructions for its Varipulse Bi-Directional Ablation Catheter after a high rate of strokes or transient ischemic attacks (TIAs) occurred during its initial use.

Following FDA approval, four out of 132 patients treated with the device experienced a stroke or TIA, which is higher than the expected 1% or less for this type of procedure. The company investigated these cases and found that the device was sometimes used in ways not recommended in the clinical trial, which may have contributed to the higher stroke rate.

Biosense Webster advises that the catheter should only be used according to the updated guidelines. Healthcare providers have been alerted to these risks and are advised to carefully review the updated instructions and discuss the risks with patients.