Johnson & Johnson Medtech bags USFDA approval for updated Varipulse Platform Irrigation Rate
New Brunswick: Johnson & Johnson MedTech has announced the U.S. Food and Drug Administration (FDA) approval of an update to the VARIPULSE pulsed field ablation (PFA) Platform’s irrigation flow rate.
“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%.
The VARIPULSE Platform is Johnson & Johnson MedTech’s Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE Catheter, TRUPULSE Generator, and CARTO 3 Mapping System VARIPULSE Software. The Platform is now approved for use in the United States, Europe, Asia Pacific, and Canada.
Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation the company is addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. Johnson & Johnson MedTech specializes in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care.
