JnJ temporarily pauses rollout of Varipulse heart device in US
Johnson & Johnson has announced a temporarily pause in the rollout of its Varipulse heart device in the United States as it investigates four reported stroke events. The decision comes following the identification of four stroke events.
According to the Manufacturer and User Facility Device Experience (MAUDE), a database of medical device reports submitted to the FDA by manufacturers, one of the reported incidents involved a patient enrolled in a Varipulse clinical study who suffered a stroke shortly after treatment.
The MAUDE database further indicates that similar complications have been reported in at least two other patients in Europe
"We think this delay should most significantly benefit (Boston's) Farapulse," JP Morgan analyst Robbie Marcus said in a note.
J&J had also paused the international rollout last year and feedback from doctors for the device has been mixed, he added.
According to Reuters, Varipulse, which uses pulsed field ablation technique to treat certain abnormal heart rhythm conditions, received approval from the U.S. Food and Drug Administration in November.
J&J said it had initiated the pause on Jan. 5, after completing more than 130 cases as part of the U.S. rollout. The company did not provide details on when it expects to resume the launch.
"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 rollout intended to collect doctors' feedback on a new technology before a broader full release.
The company added that commercial activity and cases outside the United States would not be affected by the pause
Globally, the Varipulse rollout has been successful, with over 3,000 commercial cases completed, J&J said.
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