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.”
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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%.
At Johnson & Johnson, the belief that health is everything drives the company’s mission. Its strength in healthcare innovation enables Johnson & Johnson to help build a world where complex diseases are prevented, treated, and cured, where therapies are smarter and less invasive, and solutions are tailored to each individual. Leveraging deep expertise in Innovative Medicine and MedTech, Johnson & Johnson is uniquely positioned to advance innovation across the full spectrum of healthcare. By doing so, the company aims to deliver the breakthroughs of tomorrow and make a profound impact on health for humanity.
