Investing.com -- Johnson & Johnson (NYSE: JNJ ) announced on Friday that it is set to recommence the limited market release of its VARIPULSE™ devices in the United States. The decision comes after an exhaustive investigation showed the devices were operating as planned. The investigation was initiated following a voluntary pause.

The inquiry looked into potential factors related to the device, procedure, and patients. It concluded that the VARIPULSE™ devices operated as expected and there were no performance differences among the various VARIPULSE™ system configurations available worldwide. The investigation also discovered that the risk of neurovascular events could increase if a large number of ablations were delivered, if ablations were stacked, or if ablations were conducted outside of the pulmonary veins.

In response to these findings, Johnson & Johnson plans to update the Instructions for Use (IFU) for the VARIPULSE™ Catheter globally to provide enhanced guidance. The company is also communicating with healthcare professionals who use VARIPULSE™, recommending that they review and adhere to the updated IFU and share this information with their patients.

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