Johnson & Johnson MedTech has secured FDA approval for its VARIPULSE Platform, a system designed for the treatment of drug-refractory paroxysmal atrial fibrillation (AFib). The platform integrates Pulsed Field Ablation (PFA) therapy with advanced mapping capabilities to enhance the safety and accuracy of ablation procedures.
The VARIPULSE Platform works in conjunction with the CARTO 3 Electro-anatomical Mapping System, providing electrophysiologists with precise energy delivery and real-time catheter positioning visualization. This integration facilitates a minimal- to zero-fluoro workflow through its compatibility with an intracardiac echocardiography (ICE) ultrasound portfolio, offering real-time imaging during procedures.
Clinical Data from the admIRE Study
The FDA's approval was supported by data from the admIRE prospective, multi-center, non-randomized study. The study involved 291 patients treated across 30 US healthcare centers. Key findings include:
- 100% acute procedural success, with 98% achieving first-pass isolation per vein.
- 85% peak primary effectiveness.
- A low incidence of adverse events, reported at only 2.9%.
- 25% of procedures were conducted without fluoroscopy.
Enhanced Workflow and Precision
The VARIPULSE Platform allows for a single transseptal zero exchange workflow, streamlining procedures and improving predictability. Tissue proximity indication and lesion tagging further enhance the confidence of electrophysiologists in the delivered treatment.
Jasmina Brooks, President of Johnson & Johnson MedTech Electrophysiology, stated, "With this approval, we are excited to bring the VARIPULSE Platform to electrophysiologists and patients in the US, where AFib impacts nearly eight million people. 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."
Addressing Atrial Fibrillation
Atrial fibrillation is a common heart rhythm disorder affecting millions worldwide. The VARIPULSE Platform offers a new treatment option for patients with drug-refractory paroxysmal AFib, potentially reducing the need for long-term medication and improving quality of life.
