July 14, 2025 – Johnson & Johnson MedTech has announced U.S. Food and Drug Administration (FDA) approval of an update to the Varipulse Platform’s irrigation flow rate, reflecting the company’s commitment to the evolution of pulsed field ablation (PFA) innovation following real-world 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, Electrophysiology & Neurovascular, Johnson & Johnson MedTech. “This update to the Varipulse Platform reflects our ongoing commitment to lead the evolution of PFA through meaningful, data-driven improvements that advance product performance and build procedural confidence.”
This approval follows Johnson & Johnson MedTech's milestone of surpassing 10,000 Varipulse procedures across the U.S., Europe, Canada, Japan, Hong Kong, China, Korea, Taiwan, and Australia. Notably, the platform has sustained a neurovascular adverse event rate* of less than 0.5%.
For more information on the Varipulse Platform and Johnson & Johnson MedTech’s comprehensive electrophysiology portfolio, please visit the Varipulse Platform page on jnjmedtech.com.
*This rate is calculated from internal customer reported data/complaints, and not a prospective clinical investigation. The rate reported is preliminary and pending publication.
December 01, 2025 
