At Johnson & Johnson MedTech, the health and safety of our patients is our top priority. 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 while we investigate the root cause of four reported neurovascular events in the U.S. External Evaluation. As the U.S. External Evaluation leveraged a unique platform configuration, there is no impact to commercial activity and VARIPULSE™ cases outside of the U.S.
Since beginning the External Evaluation cases with the VARIPULSE™ Platform in the U.S., we have completed more than 130 cases across 14 sites and 40 operators (as of January 3rd, 2025). Globally, the VARIPULSE™ roll out has been successful, with over 3,000 commercial cases completed.
We are working diligently to complete the investigation according to our medical safety processes and resume the U.S. External Evaluation. We expect to have more information to communicate within the coming days.
About Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circular restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke.
