Johnson & Johnson VARIPULSE receives FDA approval for platform irrigation rate

Johnson & Johnson MedTech announce approval of an update to the VARIPULSE Platform’s irrigation flow rate, reflecting the company’s commitment to the evolution of pulsed field ablation 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.”

Note that 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%.

 

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Johnson & Johnson, platform irrigation rate, VARIPULSE