Johnson & Johnson Receives FDA Approval for Updated VARIPULSE™ Platform Irrigation Rate

• New flow rate guidance designed to optimize irrigation and support consistent procedural outcomes
• 10,000+ VARIPULSE global procedures with low adverse event rate reinforces platform’s strong safety profile

Johnson & Johnson Press Release 

New Brunswick, NJ – July 14, 2025 – Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, 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.

About the VARIPULSE™ Platform
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.

Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit biosensewebster.com.

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at https://thenext.jnjmedtech.com/. Follow us at @JNJMedTech and on LinkedIn. Biosense Webster, Inc. is a Johnson & Johnson company.