Johnson & Johnson’s Pulsed Field Ablation: Real-World Evidence and Scalable Platforms Cement Market Leadership in Atrial Fibrillation

Johnson & Johnson’s Pulsed Field Ablation (PFA) has emerged as a transformative force in the treatment of atrial fibrillation (AF), leveraging robust real-world evidence and a scalable platform to secure a dominant position in a rapidly evolving market. With clinical outcomes demonstrating superior efficacy and safety compared to traditional thermal ablation methods, J&J’s PFA technologies—particularly the OMNYPULSE™ and VARIPULSE™ platforms—are reshaping the landscape of AF management.

Clinical Outcomes: A New Standard in Efficacy and Safety

The OMNYPULSE™ platform, evaluated in the Omny-IRE trial, achieved 100% acute pulmonary vein isolation (PVI) and 84.5% durable PVI at three months, with a primary adverse event rate of just 3.0% [1]. Meanwhile, the VARIPULSE™ platform demonstrated 75% primary effectiveness and a 2.9% adverse event rate in the admIRE trial [2]. These results are further supported by the Phase 2 ADVANTAGE AF study, which reported 73.4% freedom from atrial arrhythmias at follow-up, underscoring PFA’s potential for treating persistent AF [3]. The Sphere-360 PFA catheter, another J&J innovation, achieved 82.0% one-year freedom from AF recurrence, with high procedural efficiency and safety [4].

Market Adoption and Platform Scalability

J&J’s PFA technologies are not only clinically compelling but also strategically scalable. By 2024, PFA had captured 20% of the global cardiac ablation market, with projections suggesting it could dominate half of the market by year-end 2025 [5]. The launch of the VARIPULSE™ platform in the Asia-Pacific region in July 2025—fully integrated with the CARTO™ 3 electroanatomical mapping system—has further accelerated adoption in a region representing a significant portion of the AF patient population [6]. This integration enables seamless workflow optimization, a critical factor for hospitals seeking to reduce procedural complexity and costs.

Real-World Evidence: Balancing Efficacy and Practicality

Real-world studies have validated PFA’s clinical benefits while highlighting procedural nuances. A comparative analysis found PFA and radiofrequency ablation (RFA) to be similarly effective in repeat AF procedures, though PFA required longer fluoroscopic time [7]. Another multicenter study noted PFA’s shorter overall procedure times (100 vs. 70 minutes for vHPSD RFA) but longer fluoroscopy duration and increased use of general anesthesia [8]. These findings suggest that while PFA offers distinct advantages, its adoption may depend on institutional expertise and patient-specific factors.

Addressing Safety Concerns and Long-Term Competitive Edge

Despite its strengths, PFA is not without challenges. The NEMESIS-PFA registry flagged elevated biomarkers of myocardial damage, hemolysis, and renal dysfunction compared to RFA [9]. However, J&J’s iterative platform design—such as the Sphere-360 catheter’s conformable single-shot technology—demonstrates a commitment to mitigating these risks. The company’s ability to refine its offerings while maintaining a low adverse event rate positions it to outpace competitors in both innovation and safety.

Conclusion: A Sustained Leadership Position

Johnson & Johnson’s PFA platforms are redefining AF care through a combination of clinical excellence, strategic scalability, and real-world adaptability. As adoption accelerates and the company addresses remaining safety concerns, J&J is well-positioned to maintain its leadership in a market projected to grow substantially over the next decade. For investors, this represents a compelling case of innovation translating into long-term competitive advantage.

Source:
[1] Johnson & Johnson MedTech Presents 3-Month Data from Omny-IRE Clinical Trial [https://www.jnjmedtech.com/en-US/news-events/johnson-johnson-medtech-presents-3-month-data-omny-ire-clinical-trial-2025-heart-rhythm]
[2] Johnson & Johnson Launches VARIPULSE™ Platform across Asia-Pacific [https://www.jnjmedtech.com/en-US/news-events/johnson-johnson-launches-varipulse-platform-across-asia-pacific-advancing-atrial]
[3] Pulsed Field Ablation of Persistent Atrial Fibrillation With ... [https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.125.074485]
[4] One-year outcomes of a conformable single-shot pulsed ... [https://www.heartrhythmjournal.com/article/S1547-5271(25)02379-3/fulltext]
[5] PFA fired up cardiac ablation in 2024, rapid growth continues [https://www.bioworld.com/articles/716362-pfa-fired-up-cardiac-ablation-in-2024-rapid-growth-continues]
[6] Johnson & Johnson Launches VARIPULSE™ Platform across [https://www.jnjmedtech.com/en-US/news-events/johnson-johnson-launches-varipulse-platform-across-asia-pacific-advancing-atrial]
[7] Pulsed-field ablation versus radiofrequency ablation in ... [https://www.sciencedirect.com/science/article/pii/S2666501825002491]
[8] Pulsed field vs very high-power short-duration radiofrequency ablation for atrial fibrillation: Results of a multicenter, real-world experience [https://pubmed.ncbi.nlm.nih.gov/38810922/]
[9] Studies Spotlight Safety Concerns With Pulsed-Field ... [https://www.tctmd.com/news/studies-spotlight-safety-concerns-pulsed-field-ablation-af]