Update to Johnson & Johnson PFA platform gains FDA approval
The U.S. Food and Drug Administration (FDA) has approved an updated irrigation flow rate for Johnson & Johnson MedTech’s Varipulse pulsed field ablation (PFA) platform.
According to the company, which first gained FDA approval for Varipulse in November 2024, this change should help optimize the technology and lead to consistent patient outcomes.
“By learning from real-world experience and working closely with clinicians, we are continuously enhancing our technologies to improve patient care,” Michael Bodner, company group chair of Johnson & Johnson MedTech’s electrophysiology and neurovascular division, said in a statement. “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.”
According to Johnson & Johnson MedTech, Varipulse has been used more to perform more than 10,000 PFA procedures all over the world. The neurovascular adverse event rate during that time is less than 0.5%.
PFA remains one of cardiology’s most in-demand technologies
PFA has gained significant momentum in recent years, with Medtronic, Boston Scientific and Johnson & Johnson MedTech all selling FDA-approved PFA platforms. Abbott, meanwhile, has its own PFA offering that gained CE mark approval in March.
Electrophysiologists have had their eyes on this technology for quite some time, intrigued by its potential to offer high-quality outcomes with improved safety.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.