(Reuters) -Johnson & Johnson said on Wednesday it has temporarily paused the rollout of its Varipulse heart device in the United States, citing an abundance of caution as the company investigates four reported stroke events.
Varipulse, a pulsed field ablation system, received U.S. Food and Drug Administration approval in November for treating a type of abnormal heart rhythm condition.
Shares of the drug and device maker fell 3% in afternoon trade, while rivals Boston Scientific and Medtronic gained 5% and 4%, respectively.
“We are working diligently to complete the investigation according to our medical safety processes and resume the U.S. External Evaluation,” J&J said in a statement.
An external evaluation is a limited roll out intended to collect doctors’ feedback on a new technology before a broader full release.
J&J said it initiated the pause on January 5. The company added that commercial activity and cases outside the United States would not be affected by the pause.
(Reporting by Bhanvi Satija, Puyaan Singh and Sriparna Roy in Bengaluru; Editing by Tasim Zahid)
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