Johnson & Johnson MedTech gains FDA approval for Varipulse PFA system
Johnson & Johnson MedTech has received U.S. Food and Drug Administration (FDA) approval for its Varipulse pulsed field ablation (PFA) system designed to treat paroxysmal atrial fibrillation (AFib). The system previously gained European CE mark approval in February.
The FDA’s decision was based largely on data from admIRE clinical trial, which included 277 patients who underwent treatment with the Varipulse system throughout the United States. The study linked PFA with Varipulse to acute procedural success in 100% of patients and a primary effectiveness success rate of 75%. Adverse events were seen in just 2.9% of patients, and 43% of patients were able to go home on the same day they were treated.
The Varipulse Platform is now the fourth PFA offering to gain FDA approval, following Medtronic’s PulseSelect and Affera systems and Boston Scientific’s Farapulse system. It includes the Varipulse catheter, which was designed with mapping integration in mind, the Trupulse generator for powering all PFA pulse sequences and the Carto 3 System for 3D navigation and cardiac mapping.
“We have learned that with PFA technology, mapping integration is critically important for electrophysiologists to ‘see’ inside the heart and deliver pulsed field energy with accuracy,” Luigi Di Biase, MD, PhD, system director of electrophysiology with the Montefiore Health System and a professor of cardiology with the Albert Einstein College of Medicine at Montefiore Hospital,” said in a statement. “With today’s approval, electrophysiologists will have the ability to use an integrated mapping system—Carto—for PFA procedures, enabling a singular, versatile workflow, that could reduce procedure time, potentially driving positive results for patients.”
“With this approval, we are excited to bring the Varipulse Platform to electrophysiologists and patients in the U.S., where AFib impacts nearly eight million people,” added Jasmina Brooks, president of electrophysiology for Johnson & Johnson MedTech and former president of Biosense Webster. “As the only PFA platform uniquely designed for seamless integration with the Carto 3 System, we are confident that this eagerly awaited platform will be a valuable tool for physicians in performing safe, effective and efficient AFib procedures with an intuitive and reproducible workflow, and minimal-to-no fluoroscopy.”
The Varipulse Platform was designed and developed when the company was still known as Biosense Webster, a part of Johnson & Johnson MedTech. Back in September, however, Johnson & Johnson announced that Biosense Webster and some of its other healthcare technology companies would all now be going by the name Johnson & Johnson MedTech.
“By bringing our medtech businesses together under the Johnson & Johnson name, the scale of our impact in healthcare will be even more apparent, unlocking new opportunities for us to strengthen our competitiveness,” Tim Schmid, Johnson & Johnson executive vice president and worldwide chairman of medtech, said at the time.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.