Johnson & Johnson MedTech today announced FDA approval for an update to its Varipulse platform’s irrigation flow rate.
The company said the update to its pulsed field ablation (PFA) platform reflects its commitment to the evolution of PFA innovation. Its update came on the back of real-world clinical practice.
Johnson & Johnson MedTech’s Varipulse platform treats AFib with a single device that combines PFA with the Carto 3 mapping system. Its variable-loop, multi-electrode Varipulse catheter uses laser-cut nitinol tubing for its loop shape. The platform also includes TruPulse generator and the Carto 3 3D cardiac mapping system.
The company joined Medtronic and Boston Scientific as companies with PFA technologies approved for treating AFib when it received an FDA nod in November 2024. Commercial activity hit a snag earlier this year when the company temporarily halted all U.S. cases using Varipulse in January. After reviewing four reported neurovascular events, the company resumed sales a month later.
At present, the company reports that it has now surpassed 10,000 Varipulse procedures across the U.S., Europe, Canada, Japan, Hong Kong, China, Korea, Taiwan and Australia. It also notes that the platform has sustained a neurovascular adverse event rate of less than 0.5% to date.
“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.”
