Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, has officially secured an approval from the US Food and Drug Administration for its VARIPULSE™ Platform, which is designed to provide treatment of drug refractory paroxysmal Atrial Fibrillation (AFib).
According to certain reports, VARIPULSE™ Platform will facilitate AFib treatment with a single device capable of combining PFA therapy and advanced mapping with the CARTO™ 3 System, the world’s leading 3D electroanatomical cardiac mapping system.
Before we get any further into the solution, though, it must be mentioned how AFib is the most common type of cardiac arrhythmia, currently affecting more than 8 million people across the United States and more than 50 million people worldwide. In essence, one in every four adults over the age of 40 is understood to be at risk for developing AFib. However, having said that, almost one-third of patients with AFib are still not even aware that they have the condition. This is because AFib often goes unrecognized until the onset of complications.
Talk about how VARIPULSE™ Platform addresses that on a granular level, we begin from its promise to generate accuracy and safety throughout ablation procedures, something the solution does using precise energy delivery and real-time visualization of catheter positioning. The platform also arrives on the scene with an ability to deliver minimal- to zero-fluoro workflow through seamless integration with the intracardiac echocardiography (ICE) ultrasound portfolio providing real-time imaging.
“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, MD, PhD, FACC, FHRS, System Director Electrophysiology at Montefiore Health System, Professor of Medicine (Cardiology) Albert Einstein College of Medicine at Montefiore Hospital.iv “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.”
Another detail worth a mention here is rooted in VARIPULSE™ Platform’s bid to leverage tissue proximity indication and lesion tagging for providing electrophysiologists with feedback, feedback which has proven to be critical for lesion durability and long-term outcomes. Joining the same would be a prospect of single transseptal zero exchange workflow that can be used to achieve an efficient and predictable procedure.
Finally, our last piece of highlight comes from the technology’s potential in the context of addressing both routine and complex AFib ablations.
Among other things, we ought to mention how FDA’s approval of the given solution is supported by data from the admIRE study, a prospective, multi-center, non-randomized trial, where 291 patients would participate at 30 different healthcare centers across U.S. Going by the results, 100% of the participating contingent achieved acute procedural success, including 98% with first-pass isolation recorded per vein. Furthermore, 85% achieved peak primary effectiveness when 73-96 applications were applied per vein. Displaying minimal adverse events (2.9%), nearly 25% of all procedures were also performed without fluoroscopy, likely attributable to integration with the CARTO™ 3 System.
Beyond the VARIPULSE™ Platform, Johnson & Johnson MedTech is developing several other PFA technologies. This includes the investigational Dual Energy THERMOCOOL SMARTOUCH ™ SF Catheter, which is being studied to deliver both radiofrequency and PF energy, and apart from that, there is OMNYPULSE™ Catheter, a large-tip, 12 mm focal catheter with contact force sensing and a TRUEref™ reference electrode.
“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,” said Jasmina Brooks, President, Electrophysiology, Johnson & Johnson 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 AFib procedures with an intuitive and reproducible workflow, and minimal-to-no fluoroscopy.”
