J&J MedTech Resumes Varipulse Rollout After Addressing Stroke Concerns

Johnson & Johnson MedTech has announced the resumption of the U.S. rollout for its Varipulse pulsed field ablation system, following a brief pause initiated in early January due to reports of strokes in treated patients. The company's investigation into the matter has led to updated guidelines and renewed focus on healthcare professional education.

Investigation Findings and Safety Measures

The company's investigation revealed no immediate device- or procedure-related factors contributing to the reported strokes, confirming that the Varipulse system operates as intended for the treatment of atrial fibrillation. However, J&J MedTech identified potential risk factors that could escalate the chances of neurovascular complications:

• Delivering a high number of consecutive ablations
• Stacking ablations to create deeper lesions within cardiac tissue
• Performing ablations outside the area of pulmonary vein isolation

In response to these findings, J&J MedTech plans to update Varipulse's global instructions for use and will work to educate healthcare professionals on new guidance and recommended practices. These measures aim to enhance the safety profile of the device while maintaining its efficacy in treating irregular heartbeats.

Global Performance and Market Position

During the U.S. pause, Varipulse continued to be used internationally, with J&J reporting no differences in performance among the device's global configurations. Prior to the temporary halt, more than 3,000 commercial cases had been completed worldwide, following regulatory approvals in the EU and Japan last year.

The FDA granted approval for the Varipulse system in November 2024, after which it entered a limited market release and external evaluation period in the United States. Before the pause on January 5, over 130 procedures had already been performed across the country.

With the resumption of its U.S. rollout, J&J MedTech re-enters a competitive landscape dominated by established pulsed field ablation developers such as Medtronic and Boston Scientific. Notably, Boston Scientific recently reported over $1 billion in revenue during the first year of its Farapulse system, with more than 200,000 patients treated.

Meanwhile, Medtronic has bolstered its position in the market with FDA approval for a new manufacturing site in Ireland, aimed at increasing the supply of its Affera platform. This expansion has contributed to Medtronic's impressive quarterly ablation sales growth of over 20% year-over-year.

As J&J MedTech navigates the relaunch of Varipulse, the company's swift response to safety concerns and commitment to healthcare professional education may help solidify its position in the rapidly evolving pulsed field ablation market.