Jinkui Medical's Globally First Self-Expanding, Single-Rivet Bioresorbable Atrial Septal Defect Occluder Approved for Market

(Source: Shangguan News)

On June 8, the self-expanding, single-rivet, bioresorbable atrial septal defect occluder, independently developed by Shanghai Jinkui Medical Devices Co., Ltd. (hereinafter referred to as “Jinkui Medical”), was officially approved for market launch by the National Medical Products Administration.

This product is the world’s first biodegradable atrial septal defect occluder with self-expanding shape-memory properties, designed for transcatheter minimally invasive interventional closure of atrial septal defects, marking a milestone breakthrough for local enterprises in Minhang District in the field of high-end cardiovascular interventional devices.

Atrial septal defect is a common congenital heart disease, and the current mainstream treatment is transcatheter minimally invasive occlusion. Traditional occluders are mostly made of nickel-titanium memory alloy. Although they can achieve defect closure, the permanent implantation of metal in the body may cause complications such as chronic tissue damage, thrombosis, and nickel allergy, which also affect subsequent cardiac follow-up and secondary treatment for patients.

The development and launch of biodegradable occluders have provided a new direction for addressing the residual risks associated with metallic devices. However, previously marketed biodegradable products generally suffered from poor elasticity, lack of shape memory, and inadequate self-expanding recoil, which not only increased the difficulty of surgical manipulation and predisposed the occluder to dislodgement, but also readily induced postoperative arrhythmias, thereby significantly limiting their clinical application.

The product recently approved for Jinkui Medical was specifically designed to address the aforementioned pain points. It consists of a mesh body, connector, septal membrane, and suture threads. Breakthroughly, it combines “biodegradable material technology” with “material self-expanding shape-memory technology.” Its core technological system has previously been awarded the Second Prize of the National Science and Technology Progress Award.

In terms of safety, the occluder can be completely degraded within a reasonable period after the patient's defect is repaired. The degradation products are non-toxic and harmless, fundamentally eliminating the problem of long-term retention of metallic foreign bodies, making it particularly suitable for pediatric patients in the stage of growth and development. Meanwhile, its self-expanding and shape-recovering mechanical properties can effectively reduce mechanical traction and damage to the cardiac septal tissue during surgery, thereby lowering the incidence of postoperative arrhythmias.

Jinkui Medical's Self-Developed Self-Expanding Single-Rivet Bioresorbable Atrial Septal Defect Occluder (Held by the Physician in the Center)

In clinical practice, this product is suitable for minimally invasive interventional procedures, offering minimal trauma, rapid recovery, and broader applicability. It provides a new treatment option for young pediatric patients and high-risk patients who are intolerant to open surgery. Notably, the occluder supports multiple deployments and retrievals, allowing flexible intraoperative position adjustments. This feature ensures convenient and precise operation, effectively reducing procedural difficulty and improving clinical success rates.

Jinkui Medical, established in 2003 and located in Zhuanqiao Town, Minhang District, is a high-tech innovative enterprise specializing in the research and development, manufacturing, and sales of high-value consumables for cardiovascular intervention. The successful approval and market launch of this product not only vividly reflect the commitment of local sci-tech enterprises in Minhang District to deepening their focus on niche sectors and persisting in independent innovation, but also represent a significant breakthrough for Shanghai’s high-end medical device industry in overcoming key core technologies, advancing import substitution, and achieving global leadership.

Reporter: Wu Junyan

Source: District Administration for Market Regulation

Reviewed by: Liu Kenbo, Fang Yubin