Johnson & Johnson MedTech bags USFDA nod for the Varipulse Pulsed Field Ablation Platform for atrial fibrillation
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-11-08 05:30 GMT | Update On 2024-11-08 05:30 GMT
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Irvine: Johnson & Johnson MedTech has announced the U.S. Food & Drug Administration (FDA) approval of the VARIPULSE Platform for the treatment of drug refractory paroxysmal Atrial Fibrillation (AFib).
The VARIPULSE Platform is designed to enable AFib treatment with a single device that combines PFA therapy and advanced mapping with the CARTO 3 System, a 3D electroanatomical cardiac mapping system. Strategically developed for full integration with CARTO, the VARIPULSE Platform enables:
- The accuracy and safety of ablation procedures through precise energy delivery and real-time visualization of catheter positioning.
- Minimal- to zero-fluoro workflow through seamless integration with the intracardiac echocardiography (ICE) ultrasound portfolio providing real-time imaging.
- Confidence in treatment delivered through tissue proximity indication and lesion tagging, providing electrophysiologists with feedback that has proven to be critical for lesion durability and long-term outcomes
- A single transseptal zero exchange workflow for an efficient and predictable procedure
- A comprehensive solution to seamlessly address both routine and complex AFib ablations
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