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

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

Jun 08, 2026 13:47 CST Updated 13:47
Jinkui Medical

Developer and Manufacturer of Congenital Heart Disease Treatment Devices

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Audience Registration: The 2nd Global Cardiovascular Conference



Xin Weilai

June 8, 2026, the National Medical Products Administration approved it through the special review procedure for innovative medical devices,Registration Application for Shanghai Jinkui Medical Devices Co., Ltd.'s "Self-Expanding Single-Rivet Biodegradable Atrial Septal Defect Occluder"

This product is the world’s first biodegradable atrial septal defect (ASD) occluder with self-expanding shape-memory properties. It consists of a mesh structure, a connector, a separating membrane, and sutures, and is used for transcatheter minimally invasive interventional closure of atrial septal defects. The device is easy to operate in clinical practice, is 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 surveillance of this product to ensure the safety of patients using the medical device.

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Product Introduction
This product set isSelf-expanding single-rivet bioresorbable atrial septal defect occluder.
  • Equipment Composition:Composed of a mesh body, connectors, barrier membranes, and sutures;
  • Scope of Application:For transcatheter minimally invasive interventional closure of atrial septal defects;
  • Product Technical Features:Biodegradable atrial septal defect occluder with self-expanding shape-memory properties; simple clinical operation, expected to reduce mechanical injury to septal tissue, lower the incidence of arrhythmias, and enhance implantation safety for patients;
  • Regulatory Note:The drug regulatory authorities will strengthen post-market supervision of this product to ensure the safety of patients using medical devices.

Corporate Background
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Shanghai Jinkui Medical Devices Co., Ltd. is an innovative enterprise in China dedicated to the research, development, and manufacturing of interventional devices for structural heart disease.Focusing on the minimally invasive treatment of congenital heart diseases, such as atrial septal defect and ventricular septal defect.Dedicated to driving technological breakthroughs and clinical application of domestically produced high-end interventional devices through independently developed biodegradable materials and innovative designs, providing safer and more effective treatment solutions for patients with cardiovascular diseases.


Comprehensive Solutions for Cardiovascular Devices Across All Disease Indications

Structural Heart Disease  → ▌Medtronic

Vascular Disease → ▌Huamai Tech

Heart Failure → ▌Core Medical

Arrhythmia → ▌Aikemai Medical

Vascular Puncture and Closure → ▌Kegang Medical

R&D and Clinical Trial Support → ▌Xiyi Medical


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