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- The U.S. FDA has approved Johnson & Johnson MedTech’s (NYSE:JNJ) Varipulse, a device to treat drug refractory paroxysmal atrial fibrillation.
- The Varipulse platform combines pulsed field ablation therapy and advanced mapping with the Carto 3 system, a 3D electroanatomical cardiac mapping system.
- J&J said that Varipulse improves ablation procedures “through precise energy delivery and real-time visualization of catheter positioning.” Another benefit is “minimal- to zero-fluoro workflow through seamless integration with the intracardiac echocardiography ultrasound portfolio providing real-time imaging.”
- Approval was based on results from the admIRE trial. Of the nearly 300 patients enrolled, 100% saw acute procedural success, with 98% experiencing first-pass isolation recorded per vein. Also, 85% achieved peak primary effectiveness.