JnJ to resume US VARIPULSE cases
New Brunswick: Johnson & Johnson will resume the limited market release of VARIPULSE in the United States after a comprehensive investigation, following a voluntary pause, found the devices operate as intended.
On January 5, out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. VARIPULSE cases as it investigated the root cause of four reported neurovascular events in the U.S. External Evaluation.
J&J began the pause after completing more than 130 cases as part of the U.S. rollout.
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.
VARIPULSE is an important treatment option for patients with atrial fibrillation and remains available in all markets where commercially launched.
"Johnson & Johnson will update the Instructions for Use (IFU) globally for the VARIPULSE Catheter to include enhanced guidance. The Company 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," JnJ stated in a recent release.
Globally, the VARIPULSE roll out has been successful, with over 3,000 commercial cases completed.
Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation. Johnson & Johnson MedTech is addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation.
Read also: Johnson & Johnson MedTech launches CEREGLIDE 92 Catheter System for Acute ischemic stroke
