Johnson & Johnson will resume the limited market release of VARIPULSE in the United States after an investigation, following a voluntary pause, found the devices operate as intended. The pause last month while the company looked into the root cause of four reported neurovascular events.
The company said it will update the Instructions for Use (IFU) globally for the VARIPULSE Catheter to include enhanced guidance.
The investigation into potential device-, procedure-, and patient-related factors concluded that VARIPULSE devices operate as intended and there is no difference in the performance of the available VARIPULSE system configurations globally. The investigation found 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.
Johnson & Johnson is communicating with healthcare professionals using VARIPULSE to recommend 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.
