Bengaluru: Johnson & Johnson said on Wednesday it had temporarily paused the rollout of its Varipulse heart device in the United States, as the company investigates four reported stroke events.
The Manufacturer and User Facility Device Experience (MAUDE), a database of medical device reports submitted to the FDA by manufacturers, shows a patient enrolled in a Varipulse study had a stroke shortly after treatment.
It adds that at least two other patients in Europe had similar complications.
Shares of the company fell 3% to a three-year low of $141.44 in afternoon trade. Rivals Boston Scientific and Medtronic rose 5% and 4%, respectively, with at least two analysts saying J&J’s pause could be beneficial for the two companies.
“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.
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.
(Reporting by Bhanvi Satija, Puyaan Singh and Sriparna Roy in Bengaluru; Editing by Tasim Zahid)
