J&J pauses US rollout of Varipulse heart device after stroke reports

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J&J pauses US rollout of Varipulse heart device after stroke reports

^{Published on 2025-01-09 00:21:00 - 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.

Johnson & Johnson has decided to temporarily halt the rollout of its new heart device in the U.S. to investigate potential risks of stroke associated with its use. This decision comes after the company identified a higher than expected rate of strokes in patients who received the device during clinical trials. The device in question is designed to treat atrial fibrillation, a common heart rhythm disorder. J&J is working closely with the U.S. Food and Drug Administration (FDA) to assess the data and determine the next steps. The company emphasized that patient safety is their top priority and they are committed to ensuring the device's safety before resuming its distribution.

Read the Full Reuters Article at:
[ https://www.reuters.com/business/healthcare-pharmaceuticals/jj-pauses-rollout-heart-device-us-investigate-stroke-risk-2025-01-08/ ]

Contributing Sources

Reuters

N@N

J&J pauses US rollout of Varipulse heart device after stroke reports