J&J MedTech Earns FDA Approval for Varipulse PFA Irrigation Update

Johnson & Johnson MedTech has received U.S. Food and Drug Administration (FDA) approval for an update to the Varipulse pulsed field ablation (PFA) platform’s irrigation flow rate.

The approval follows the company’s milestone of passing 10,000 Varipulse procedures in the U.S., Europe, Canada, Japan, Hong Kong, China, Korea, Taiwan, and Australia. Notably, the platform has sustained a neurovascular adverse event rate of under 0.5%.

J&J MedTech launched the Varipulse PFA in the Asia-Pacific region last week.

Varipulse enables atrial fibrillation (AFib) treatment with one device that combines pulsed field ablation (PFA) therapy and advanced mapping with the Carto 3 system, a 3D electroanatomical cardiac mapping system. According to J&J, Varipulse’s precise energy delivery and real-time catheter position visualization with Carto 3 enable safety and accuracy in ablation procedures.

It also, according to the company, enables safe and efficient therapy with minimal to no fluoroscopy exposure and is compatible with deep and/or conscious sedation. Varipulse received FDA approval in November 2024.

“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.”