J&J wins approval of Varipulse atrial fibrillation device
by Contributor since / Followers
18 hours ago
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 theintracardiac 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.