FDA Approves Johnson & Johnson MedTech’s VARIPULSE™ Platform, Pioneering Integrated AFib Treatment in the U.S.
Johnson & Johnson MedTech, a global leader in cardiac health solutions, has received FDA approval for its VARIPULSE™ Platform, the first Pulsed Field Ablation (PFA) system in the U.S. to integrate fully with the CARTO™ 3 Electro-anatomical Mapping System. Designed to enhance the treatment of drug-refractory paroxysmal atrial fibrillation (AFib), this innovative platform combines PFA therapy with CARTO™’s advanced mapping capabilities, enabling precise, real-time visualization of catheter positioning and reducing reliance on fluoroscopy. “This approval marks a pivotal step forward, allowing electrophysiologists to treat AFib with a streamlined workflow that can improve patient outcomes,” said Luigi Di Biase, MD, PhD, System Director at Montefiore Health System.
Supported by Johnson & Johnson’s admIRE study, the VARIPULSE™ Platform demonstrated a 12-month success rate of 85% and achieved acute procedural success across 291 patients. Notably, the study recorded a 98% success rate for first-pass isolation, minimal adverse events, and a significant number of procedures performed without fluoroscopy. These results underscore the platform’s ability to deliver accurate, safe ablations with reduced procedural time and enhanced reproducibility. Jasmina Brooks, President of Electrophysiology at Johnson & Johnson MedTech, expressed confidence in the platform’s impact, stating, “With AFib affecting nearly eight million Americans, this advanced solution represents a valuable tool for safe and efficient procedures.”
In addition to the VARIPULSE™ Platform, Johnson & Johnson MedTech is developing further PFA innovations, including the investigational Dual Energy THERMOCOOL SMARTOUCH™ SF Catheter and OMNYPULSE™ Catheter, designed to broaden treatment options and enhance procedural efficiency for electrophysiologists. The VARIPULSE™ Platform is now available in the U.S., Europe, Japan, and Canada, following its successful evaluation with over 1,000 patients globally.
