XuanYu Medical's Cardiac Pulsed Field Ablation System Receives NMPA Approval

Officially approved for marketing on 2025.02.26

On February 26, 2025, an innovative product independently developed by ShineyoMedicalSHINERHYTHM™Cardiac Pulsed Field Ablation System andRHYTHPULSE™ShineyoMedical's Single-Use Cardiac Pulse Electric Field Ablation Catheter Approved by NMPA for Class III Medical Device Registration. The two products are used in conjunction to perform atrial fibrillation ablation using a high-voltage pulse electric field, causing irreversible electroporation in diseased cells leading to necrosis or apoptosis. This product selectively destroys myocardial tissue while avoiding the risk of damage to surrounding tissues caused by heat transfer, benefiting more patients with drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.