Johnson & Johnson (J&J) MedTech has announced the US Food and Drug Administration (FDA) approval of the Varipulse pulsed field ablation (PFA) platform for the treatment of drug-refractory paroxysmal atrial fibrillation (AF).
“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,” said Luigi Di Biase (Montefiore Health System, New York, USA). “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.”
The Varipulse platform is designed to enable AF treatment with a single device that combines PFA therapy and advanced mapping via the Carto 3 system, which J&J MedTech claims is the world’s leading 3D electroanatomical cardiac mapping system. Strategically developed for full integration with Carto, J&J MedTech also notes that the Varipulse platform enables:
- The accuracy and safety of ablation procedures through precise energy delivery and real-time visualisation of catheter positioning
- Minimal- to zero-fluoro workflow through seamless integration with the intracardiac echocardiography (ICE) ultrasound portfolio, providing real-time imaging
- Confidence in treatment delivered through tissue proximity indication and lesion tagging, providing electrophysiologists with feedback that has proven to be critical for lesion durability and long-term outcomes
- A single transseptal zero exchange workflow for an efficient and predictable procedure
- A comprehensive solution to seamlessly address both routine and complex AF ablations
The recent FDA approval of Varipulse has been supported by data from the admIRE study—a prospective, multicentre, non-randomised trial. Twelve-month outcome data from the pivotal phase of the admIRE study—now published in Circulation—show that, among 291 patients across 30 healthcare centres in the USA, 100% achieved acute procedural success, including 98% with first-pass isolation recorded per vein. In addition, the study achieved 85% peak primary effectiveness when 73–96 applications were applied per vein (n=85); showed minimal adverse events (2.9%); and saw 25% of procedures performed without fluoroscopy, which J&J MedTech believes is likely attributable to integration with the Carto 3 system.
“With this approval, we are excited to bring the Varipulse platform to electrophysiologists and patients in the USA, where AF impacts nearly eight million people,” said Jasmina Brooks, president of Electrophysiology at J&J MedTech. “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 AF procedures with an intuitive and reproducible workflow, and minimal-to-no fluoroscopy.”
“With a growing prevalence of AF around the world, innovative solutions are critical in expanding options for patients, and helping electrophysiologists treat AF effectively and efficiently,” added Andrea Natale (St David’s Medical Center, Austin, USA). “The Varipulse platform enables efficient procedures with a favourable safety profile, allowing me to treat more patients and get them back to their normal lives.”
In addition to the Varipulse platform, J&J MedTech states that it is committed to developing a comprehensive suite of PFA technologies, including the investigational dual-energy Thermocool Smarttouch Surroundflow (SF) catheter—which is being studied to deliver both radiofrequency and pulsed field energy—and the Omnypulse catheter, a large-tip, 12mm focal catheter with contact force sensing and a Trueref reference electrode.
