Johnson & Johnson MedTech (NYSE: JNJ) has announced that the U.S. Food and Drug Administration (FDA) has approved an enhancement to the irrigation flow rate for its Varipulse pulsed field ablation (PFA) platform, reinforcing the company’s commitment to continuous innovation in atrial fibrillation (AFib) treatment.
This latest update, informed by insights from real-world clinical practice, underscores the company’s focus on optimizing performance and safety in its electrophysiology offerings.
The Varipulse platform is designed to treat AFib using a single system that integrates PFA with the Carto 3 cardiac mapping technology. At the core of the platform is a variable-loop, multi-electrode catheter constructed with laser-cut nitinol tubing, alongside the TruPulse generator and the Carto 3 3D mapping system.
Johnson & Johnson MedTech entered the competitive PFA market in November 2024 when it received FDA clearance, joining peers such as Medtronic and Boston Scientific. However, the company temporarily paused U.S. procedures in January 2025 following reports of four neurovascular events. Sales resumed in February after a thorough review.
To date, the Varipulse platform has been used in over 10,000 procedures across the United States, Europe, Canada, Japan, Hong Kong, China, Korea, Taiwan, and Australia. The platform continues to demonstrate a strong safety profile, maintaining a neurovascular adverse event rate of less than 0.5%.
“Our focus is on leveraging real-world insights and clinical partnerships to continually refine our technologies and enhance patient outcomes,” said Michael Bodner, Company Group Chair, Electrophysiology & Neurovascular at Johnson & Johnson MedTech. “This irrigation update to the Varipulse platform exemplifies our ongoing commitment to driving PFA innovation with data-backed improvements that support procedural reliability and physician confidence.”