Home Shanghai JinKui Medical Receives NMPA Approval for World’s First Self-Expanding, Single-Rivet, Bioresorbable Atrial Septal Defect Occluder

Shanghai JinKui Medical Receives NMPA Approval for World’s First Self-Expanding, Single-Rivet, Bioresorbable Atrial Septal Defect Occluder

Jun 08, 2026 17:40 CST Updated 17:40
Jinkui Medical

Developer and Manufacturer of Congenital Heart Disease Treatment Devices

图片

Recently, the National Medical Products Administration 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, connector, separator membrane, and sutures, and is used for transcatheter minimally invasive interventional closure of atrial septal defects. The device offers ease of operation in clinical practice, is expected to reduce mechanical injury to septal tissue, thereby lowering the incidence of arrhythmias and enhancing implantation safety for patients.


Recommended Reading


Three Innovative Medical Devices Approved for Market Launch


Request for Comments on Four Registration Guidance Documents


Announcement on Work Related to the Adjustment of Medical Device Classification


Application for Cancellation of Registration Certificates for Five Class II Medical Devices

图片