Johnson & Johnson announced that 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 it investigates the 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.,” the company said in a statement. It added, “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. 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.” Shares of Johnson & Johnson are down 3% to $142.12 in late-day trading.
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