Johnson & Johnson MedTech Receives FDA Approval for Varipulse PFA Platform Update
Jul 24,2025
Johnson & Johnson MedTech, through its electrophysiology division Biosense Webster, has announced an FDA-approved update to its Varipulse™ pulsed field ablation (PFA) platform. The update involves an adjustment to the system’s irrigation flow rate, developed in response to real-world clinical feedback and ongoing product refinement.
A Next-Generation PFA System for AFib Treatment
The Varipulse platform is designed as an all-in-one PFA solution for atrial fibrillation (AFib) treatment, integrating with the Carto® 3 3D mapping system to provide precise anatomical guidance. At the heart of the platform is the Varipulse catheter, featuring a variable-loop, multi-electrode design constructed from laser-cut nitinol tubing. The system also includes the TruPulse™ generator, enabling controlled energy delivery for non-thermal tissue ablation.
This unique combination enables efficient and reproducible procedures, supporting electrophysiologists in achieving durable outcomes with minimal collateral damage.
Real-World Data Driving Improvements
Since receiving initial FDA clearance in November 2024, the Varipulse system has been adopted in over 10,000 procedures across the U.S., Europe, Canada, Japan, Korea, China, Hong Kong, Taiwan, and Australia. Although the company temporarily paused U.S. usage in early 2025 due to four reported neurovascular events, it resumed procedures following an internal review and has since maintained a reported neurovascular adverse event rate below 0.5%.
The recently approved update reflects Johnson & Johnson MedTech’s dedication to iterative development based on clinical practice. “By learning from real-world experience and working closely with clinicians, we are continuously enhancing our technologies to improve patient care,” said Michael Bodner, Company Group Chair of Electrophysiology & Neurovascular.
Leading the Evolution of PFA Therapy
The FDA’s latest approval reinforces Johnson & Johnson MedTech’s position as a leader in the rapidly evolving field of non-thermal cardiac ablation. Alongside other key players like Medtronic and Boston Scientific, the company is contributing to the global shift toward safer and more targeted AFib therapies.
Jul 24,2025
Category：
In The News
Related Information
Videos
Watch the video，Learn more about our products and services.Diagsensor is dedicated to the research and development of ultra-micro sensors for vital signs monitoring
Learn MoreSocial Media
Our Social Media Channels Keep You Informed.
No data