Johnson & Johnson MedTech received FDA approval for an updated irrigation flow rate on its Varipulse pulsed field ablation (PFA) system, initially cleared in November 2024.
The modification aims to optimize device performance and ensure consistent clinical outcomes, reflecting lessons learned from real-world use. The Varipulse platform has now supported over 10,000 PFA procedures globally with a neurovascular adverse event rate under 0.5%.
Michael Bodner, group chair of electrophysiology and neurovascular, emphasized the company’s commitment to advancing PFA through data-driven improvements that enhance safety and procedural confidence.
PFA technology continues to gain traction, with major players including Medtronic, Boston Scientific, and Abbott expanding their offerings.
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