Johnson & Johnson MedTech has secured FDA approval for its VARIPULSE Platform, a system designed for the treatment of drug-refractory paroxysmal atrial fibrillation (AFib). This approval marks a significant advancement in the treatment of AFib, which affects nearly eight million people in the US.
The VARIPULSE Platform uniquely integrates Pulsed Field Ablation (PFA) therapy with advanced mapping capabilities. This integration allows electrophysiologists to deliver precise energy, enhancing the safety and accuracy of ablation procedures through real-time catheter positioning visualization, facilitated by the CARTO 3 Electro-anatomical Mapping System. The platform also supports minimal-to-zero fluoroscopy workflows by integrating with an intracardiac echocardiography (ICE) ultrasound portfolio, providing real-time imaging.
Clinical Trial Data
The FDA's decision was supported by data from the admIRE study, a prospective, multi-center, non-randomized trial. The study, which included 291 patients across 30 US healthcare centers, demonstrated a 100% acute procedural success rate, with 98% achieving first-pass isolation per vein. Furthermore, 85% of patients reached peak primary effectiveness, with a minimal adverse event rate of just 2.9%. Notably, 25% of the procedures were conducted without fluoroscopy.
Key Features and Benefits
The VARIPULSE Platform offers several key benefits, including tissue proximity indication and lesion tagging, which provide electrophysiologists with increased confidence in treatment delivery. The platform also enables a single transseptal zero exchange workflow, streamlining procedures for efficiency and predictability. According to Jasmina Brooks, President of Johnson & Johnson MedTech Electrophysiology, the VARIPULSE Platform is uniquely designed for seamless integration with the CARTO 3 System, making it a valuable tool for physicians performing AFib procedures.
Addressing Unmet Needs in AFib Treatment
Atrial fibrillation is a common heart rhythm disorder that can lead to serious complications, including stroke. Current treatment options include medication and catheter ablation, but some patients do not respond well to drug therapy, highlighting the need for innovative solutions like the VARIPULSE Platform. This platform offers a comprehensive approach to AFib ablation, potentially improving outcomes and quality of life for patients with drug-refractory paroxysmal AFib.
