Key Highlights
- Near-perfect acute effectiveness (99.7%) with zero strokes strengthens confidence in J&J MedTech’s VARIPULSE™ Platform.
- Real-world substudy across 791 patients and 20 European centers highlights scalability and reproducibility.
- ESC 2025 results position J&J as a frontrunner in next-generation atrial fibrillation therapies.
Breakthrough Clinical Data from ESC 2025
Johnson & Johnson MedTech unveiled results from the VARIPURE substudy of the SECURE trial at the 2025 European Society of Cardiology Congress in Madrid. Involving 791 patients across 20 centers and 62 operators, the study showed an impressive 99.7% acute pulmonary vein isolation (PVI) success rate and a low 0.6% primary adverse event rate, with zero strokes reported. These outcomes underscore both safety and reproducibility, reinforcing the VARIPULSE™ Platform’s potential to transform atrial fibrillation care.
Real-World Validation of VARIPULSE™ Platform
Unlike retrospective registry data, VARIPURE deployed rigorous upfront monitoring and electronic data capture, offering higher scientific integrity. The results highlight seamless integration of the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 System across diverse procedural workflows, strengthening physician confidence in pulsed field ablation (PFA) adoption at scale.
Expanding Clinical Evidence Beyond Europe
Complementing VARIPURE, J&J presented data from the REAL AF Registry across 70 sites in the U.S. and Canada. With nearly 200 procedures, the registry confirmed high procedural success and no device-related hospitalizations. Together, these datasets highlight the VARIPULSE™ Platform’s adaptability across geographies and patient populations, positioning it as a potential new global standard in AF ablation.
Strategic Implications for J&J MedTech in AF Market
By combining robust real-world data with broad international regulatory approvals (U.S., EU, Asia-Pacific, Canada, Latin America), J&J MedTech is moving decisively to capture share in the rapidly growing PFA market. With competitors like Medtronic and Boston Scientific also racing to scale PFA adoption, J&J’s consistency, safety profile, and workflow integration offer a clear differentiation advantage.
Johnson & Johnson MedTech
Johnson & Johnson MedTech is part of Johnson & Johnson (NYSE: JNJ), a global leader in healthcare innovation. The company develops advanced medical technologies across surgery, orthopedics, interventional solutions, and vision, with a mission to improve patient outcomes and expand access to life-saving care worldwide.
Biosense Webster (a Johnson & Johnson MedTech company)
Biosense Webster, part of Johnson & Johnson MedTech, is a worldwide leader in the science of diagnosing and treating cardiac arrhythmias. Its portfolio of electrophysiology solutions—including the CARTO™ 3 Mapping System and VARIPULSE™ Platform—empowers physicians with advanced tools to deliver safer, more effective, and minimally invasive treatment for atrial fibrillation and other complex heart rhythm disorders.
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