FDA Greenlights J&J's Varipulse Device for Safer Atrial Fibrillation Treatment

FDA approves Johnson & Johnson's Varipulse for targeted atrial fibrillation treatment, enhancing precision and safety

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Nov 07, 2024
Summary
  • Johnson & Johnson’s Varipulse device wins FDA approval, offering safer, more precise atrial fibrillation treatment with advanced imaging.
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Varipulse devices developed by Johnson & Johnson MedTech (JNJ, Financial) have been approved by the U.S. Food and Drug Administration for treating paroxysmal atrial fibrillation in individuals not responsive to drugs. Varipulse blends the Carto 3 system, Johnson & Johnson's 3D cardiac mapping technology, with pulsed-field ablation treatment. By supplying controlled energy and real-time catheter placement visualization, the gadget is meant to increase the accuracy of ablation techniques.

Varipulse additionally provides a process that minimizes or eliminates fluoroscopy by merging with intracardiac echocardiography to lower radiation exposure for patients and staff. Based on results from the admIRE trial, which had over 300 participants, there was a 100% success rate in acute operations; 98% of patients attained first-pass isolation per vein, and 85% of them met the main efficacy targets. With sophisticated imaging and enhanced safety features, Johnson & Johnson claims the Varipulse platform presents a fresh approach to atrial fibrillation therapy.

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