Bengaluru: Johnson & Johnson said on Friday it resumed the limited market release of its Varipulse heart device in the United States after an investigation found the devices operate as intended.
In January, J&J paused the heart device, citing an abundance of caution as it investigated four reported stroke events.
Varipulse, which uses a pulsed field ablation technique to treat certain abnormal heart rhythm conditions, received approval from the U.S. Food and Drug Administration last year.
J&J initiated the pause after completing more than 130 cases as part of the U.S. rollout.
The probe concluded that the Varipulse devices function as intended with no performance differences across global configurations, the company said in a statement.
However, the inquiry found that the risk of neurovascular events may rise if excessive, stacked or misplaced ablations outside of the pulmonary veins are delivered, J&J said.
The medical device maker said it would update the usage guidance for Varipulse Catheter device globally.
The Varipulse rollout has been successful around the world, with over 3,000 commercial cases completed, the company has said. J&J said the device remains available in all markets where it was commercially launched. (Reporting by Mrinmay Dey in Bengaluru; Editing by William Mallard)
