Johnson & Johnson MedTech's Varipulse PFA System Receives FDA Approval for Atrial Fibrillation

Key Insights

• Johnson & Johnson MedTech's Varipulse pulsed field ablation (PFA) system has gained FDA approval for treating atrial fibrillation (AFib).
• The Varipulse platform integrates with the Carto 3 System, potentially reducing procedure time and improving outcomes for AFib patients.
• The approval brings a new tool to electrophysiologists in the U.S. for performing safe, effective, and efficient AFib ablation procedures.

Johnson & Johnson MedTech has announced FDA approval for its Varipulse pulsed field ablation (PFA) system designed for the treatment of atrial fibrillation (AFib). This approval marks a significant advancement in electrophysiology, offering a new tool for physicians to perform safer and more efficient AFib ablation procedures.

The Varipulse platform is uniquely designed for seamless integration with the Carto 3 System, Johnson & Johnson's advanced mapping system. According to Luigi Di Biase, MD, system director of electrophysiology with the Montefiore Health System, this integration is critically important as it allows electrophysiologists to visualize the heart and accurately deliver pulsed field energy. The integrated workflow could reduce procedure time and potentially drive positive results for patients.

Clinical Impact and Design

With nearly eight million people in the U.S. affected by AFib, the approval of the Varipulse platform addresses a significant medical need. Jasmina Brooks, president of electrophysiology for Johnson & Johnson MedTech, expressed excitement about bringing the Varipulse Platform to electrophysiologists and patients in the U.S. The platform is designed to provide an intuitive and reproducible workflow with minimal-to-no fluoroscopy, enhancing both safety and efficiency.

The Varipulse platform was developed under Biosense Webster, which is now part of Johnson & Johnson MedTech. The consolidation of Johnson & Johnson's medtech businesses aims to amplify their impact in healthcare and strengthen their competitiveness, according to Tim Schmid, executive vice president and worldwide chairman of medtech at Johnson & Johnson.

Expert Perspectives

Luigi Di Biase emphasized the importance of mapping integration with PFA technology, stating that it enables electrophysiologists to "see" inside the heart and deliver pulsed field energy with accuracy. He believes that the integrated Carto system will provide a versatile workflow, potentially leading to reduced procedure times and improved patient outcomes.