J&J Resumes Varipulse Rollout Amid Safety Concerns, Competitors Poised to Benefit

Johnson & Johnson has resumed the limited market release of its Varipulse pulsed field ablation (PFA) device in the United States following a brief pause to investigate reported neurovascular events. The company's return to the market comes with updated instructions for use, as analysts warn that safety concerns may hinder the product's adoption and benefit competitors in the rapidly evolving PFA landscape.

Investigation Results and Safety Considerations

J&J's investigation concluded that the Varipulse device operates as intended, with no difference in performance between system configurations used globally. However, the company found that the risk of neurovascular events may increase under certain circumstances, including when a high number of ablations are performed, when ablations are stacked, or when they are delivered outside of the pulmonary veins.

In response to these findings, J&J has updated its instructions for use and is actively engaging with healthcare professionals to review the new guidelines and share information with patients. The company stated, "Neurovascular events may increase if a high number of ablations, the stacking of ablations, and/or ablations outside of the pulmonary veins are delivered."

Market Implications and Analyst Perspectives

While RBC Capital Markets analysts view the resumption as "a positive step" for Varipulse, allowing J&J to expand into the fast-evolving U.S. PFA market, they acknowledge that the company faces challenges in regaining momentum. Interactions with doctors suggest that the pause "impacted their enthusiasm for device uptake," necessitating "meaningful steps to educate healthcare professionals" to drive adoption.

J.P. Morgan analysts present a more pessimistic outlook, warning that the investigation's findings "could significantly hinder the product's rollout in the U.S. and globally" and lead doctors to "de-prioritize Varipulse." They argue that safety is the main draw of PFA technology, and J&J's rivals now appear to have a cleaner profile in comparison.

Competitive Landscape

The safety concerns surrounding Varipulse may create opportunities for J&J's competitors in the PFA market. Boston Scientific's Farapulse device, which has already seen strong market performance, is positioned to be "the biggest beneficiary of Varipulse's challenges," according to J.P. Morgan analysts. Additionally, the situation may simplify the rollout of Medtronic's Affera and PulseSelect devices, as well as Abbott's forthcoming Volt system.

Analysts note that Boston Scientific and Medtronic's competing PFA devices now boast cleaner labels with less restrictive language compared to Varipulse. This distinction in safety profiles could play a crucial role in shaping physician preferences and market dynamics in the coming months.