Dive Brief:
- Johnson & Johnson said Friday it has resumed the use of its Varipulse pulsed field ablation (PFA) device in the U.S. after finding the technology works as intended.
- The company paused cases in January, two months after winning approval in the U.S., to review four reported neurovascular events. J&J found the devices operate as intended but the risk of neurovascular events may increase in certain circumstances.
- With J&J updating its instructions for use to reflect the risk, J.P. Morgan analysts said in a note to investors that Boston Scientific’s and Medtronic’s rival PFA devices have cleaner labels with less restrictive language. The analysts expect Boston Scientific to benefit from J&J’s challenges.
Dive Insight:
J&J in November became the third device maker to win Food and Drug Administration approval for a PFA system, positioning the company to market Varipulse as a treatment for atrial fibrillation. The company had completed more than 130 cases across 14 sites by early January but then paused the rollout in response to neurovascular events. J&J continued the overseas rollout, where the company uses a different platform configuration.
The investigation found Varipulse operates as intended and there is no difference in the performance of the available system configurations globally. J&J responded to the finding by resuming the limited market release of the PFA device in the U.S.
RBC Capital Markets analysts said the resumption is “a positive step” for Varipulse that will allow J&J to expand into the “fast evolving” U.S. PFA market. However, the RBC analysts and their counterparts at J.P. Morgan said J&J has work to do to regain momentum.
J&J said it found “neurovascular events may increase if a high number of ablations, the stacking of ablations, and/or ablations outside of the pulmonary veins are delivered.” The finding led the company to update the instructions for use. J&J is asking healthcare professionals who use Varipulse to review the updated instructions and share information with patients.
RBC analysts’ interactions with doctors suggest the pause “impacted their enthusiasm for device uptake.” The analysts said J&J will have “to take meaningful steps to educate healthcare professionals,” but they continue to believe the company “should be able to drive Varipulse adoption.”
J.P. Morgan analysts were more downbeat. Physician feedback on Varipulse is “already mixed” based on their channel checks, the analysts said, and the findings of the investigation “could significantly hinder the product’s rollout in the U.S. and globally” and lead doctors to “de-prioritize Varipulse.” That prediction reflects the belief safety is the main draw of PFA, and J&J’s rivals have a cleaner profile.
Boston Scientific’s Farapulse, which has made an explosive launch, could be “the biggest beneficiary of Varipulse’s challenges,” the J.P. Morgan analysts said. The analysts said J&J’s problems also simplify the rollout of Medtronic’s Affera and PulseSelect devices and, once it comes to market, Abbott’s Volt.
