Shanghai JinKui Medical's Self-Expanding, Single-Rivet Biodegradable Atrial Septal Defect Occluder Gains NMPA Approval

The Municipal Drug Administration stated that the National Medical Products Administration recently approved the registration application for the innovative product “Self-Expanding Single-Rivet Bioresorbable Atrial Septal Defect Occluder” from Shanghai Jinkui Medical Devices Co., Ltd.

This product is the world’s first biodegradable atrial septal defect (ASD) occluder with self-expanding shape-memory properties. It consists of a mesh body, connectors, a separation membrane, and sutures, and is used for transcatheter minimally invasive interventional closure of atrial septal defects.The product is easy to operate in clinical use, expected to reduce mechanical injury to septal tissue, thereby lowering the incidence of arrhythmias and enhancing implantation safety for patients.

The drug regulatory authorities will strengthen post-market supervision of this product to ensure the safety of patients using medical devices.

Source: Municipal Drug Administration

Editor: Liu Tangyi