"Johnson & Johnson's electrophysiology division recuperates amid competition with PFA, defiantly refusing to succumb"
Johnson & Johnson's (J&J) electrophysiology unit saw a significant 11% year-over-year growth in the second quarter, reaching $1.47 billion. The growth is largely attributed to the success of J&J's Varipulse PFA platform, which holds a competitive yet emerging position in the pulsed field ablation (PFA) market.
The Varipulse system, integrated with J&J’s Carto 3 mapping system, has been used in over 10,000 procedures worldwide. It has demonstrated growing adoption across North America, Europe, and Asia-Pacific regions. The platform received FDA approval for treating atrial fibrillation (AFib) in November 2024, with an update for irrigation flow rate following in July 2025.
Despite a temporary pause in U.S. use early 2025 due to neurovascular event reports, the Varipulse platform has maintained a low adverse event rate (<0.5%), supporting procedural safety and confidence.
In the broader PFA market, systems from Boston Scientific, Medtronic, and Johnson & Johnson are seen as key disruptors of traditional thermal ablation technologies. The U.S. market for PFA was estimated at approximately $535.9 million in 2024, with an anticipated compound annual growth rate (CAGR) exceeding 31% over the next decade. However, tariffs on imported components may pose challenges by raising costs and slowing adoption.
Compared to Boston Scientific and Medtronic, J&J appears to have a slightly later entry, with FDA approval coming in late 2024. However, J&J has quickly built significant procedural volume and incorporated iterative improvements, indicating a strong commitment to innovation and market presence.
Meanwhile, Boston Scientific has seen its electrophysiology unit grow by triple digits since launching its Farapulse PFA system. Medtronic has also reported strong success for its PFA offerings.
J&J's Varipulse PFA platform has now completed more than 10,000 cases globally. The company also plans to file a de novo application for its Ottava soft tissue surgical robot to the Food and Drug Administration in Q1 2026. The Ottava system received an investigational device exemption from the FDA late last year.
Despite the strong growth, J&J's electrophysiology unit's growth still trails that of rival Boston Scientific. However, J&J's Chief Financial Officer, Joseph Wolk, remains confident that the company can retain its global market leadership position in the electrophysiology space.
In conclusion, Varipulse is establishing itself as a prominent PFA platform with expanding global reach and incremental technological updates, competing closely with Boston Scientific and Medtronic amid a rapidly growing market environment projected for continued double-digit gains.
- The Varipulse PFA platform, approved by the FDA for treating atrial fibrillation, has demonstrated significant growth and adoption across various regions worldwide.
- Despite a temporary pause due to neurovascular event reports, the Varipulse system has maintained a low adverse event rate, supporting procedural safety and confidence.
- J&J's electrophysiology unit, which includes the Varipulse PFA system, saw a noteworthy 11% year-over-year growth in the second quarter, reaching $1.47 billion.
- In the broad medical technology (medtech) industry, AI and diagnostics are expected to play a crucial role in the future of healthcare, particularly in the field of news and research.
- J&J's Chief Financial Officer, Joseph Wolk, is confident that the company can retain its global market leadership position in the electrophysiology space, despite trailing behind rival Boston Scientific in growth.
- J&J plans to file a de novo application for its Ottava soft tissue surgical robot with the FDA in Q1 2026, following an investigational device exemption from the FDA late last year.
