Johnson & Johnson announced a randomized, head‑to‑head clinical trial—named PERSIGMA—to compare its Varipulse Pro pulsed‑field ablation (PFA) platform with Boston Scientific’s Farapulse system. The study will enroll up to 466 patients across 50 sites and will evaluate procedural outcomes, safety, and efficacy in atrial fibrillation ablation.
Varipulse Pro, which received CE mark approval in March, incorporates a new, faster pulse sequence that the company claims makes ablation five times faster than its predecessor. The platform also integrates with the Carto 3 mapping system for enhanced precision and maintains a lower temperature profile to reduce collateral injury. The trial’s design will provide the first direct, comparative evidence between the two leading PFA technologies.
"Having this head‑to‑head study to compare pulsed field ablation technologies is extremely important for the electrophysiology community since it will help us better understand how they perform relative to one another and make more informed treatment decisions in daily practice," said Dr. Devi Nair, co‑principal investigator of PERSIGMA. "PERSIGMA marks an exciting next phase in PFA research—moving the field forward with the rigorous, head‑to‑head evidence we need in persistent AF," added Dr. Andrea Natale, co‑principal investigator.
Johnson & Johnson’s strategy to establish Varipulse Pro as a competitive alternative follows its earlier Varipulse system, which faced safety concerns. The company’s MedTech segment grew 4.6% in Q1 2026, with cardiovascular sales up 13% and Varipulse driving much of that momentum. "We are confident in our PFA technology, our innovation pipeline and in the strength of our integrated portfolio," said Gregory Michaud, chief medical and scientific officer of Electrophysiology. "The introduction of VARIPULSE Pro in Europe reflects our commitment to advancing our PFA platforms through continuous innovation, enhancing procedural experience while maintaining the consistency and precision physicians expect from the VARIPULSE Platform," added Michael Bodner, company group chair.
Boston Scientific remains the U.S. market leader in PFA, with its Farapulse system supported by extensive clinical evidence. The company reported Q1 2026 net sales of $5.203 billion, with its cardiovascular business—where Farapulse is a key product—contributing significantly to that figure. The head‑to‑head trial will test whether Varipulse Pro can match or surpass Farapulse’s performance, potentially reshaping market share in a sector projected to reach $16.95 billion by 2035 with a 7.4% CAGR from 2026 to 2035.
The atrial fibrillation market, which affects more than 50 million people worldwide, is a major driver of the growing electrophysiology ablation sector. Global cardiac ablation is expected to reach $22.27 billion by 2035, with a 14.24% CAGR, while the electrophysiology ablation catheter market is projected to grow to $17.6 billion by 2035 from $6.1 billion in 2025. The PERSIGMA trial’s outcomes will therefore have implications for both companies’ future revenue streams and competitive positioning in a high‑growth market.
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