JinKui Medical's Biodegradable Atrial Septal Defect Occluder Enters NMPA Innovation Review Channel

On July 2, 2025, the NMPA announced the Special Review Application Examination Results for Innovative Medical Devices Public Notice (No. 6 of 2025), which includes14 ProductsEnter the innovation channel.

IncludingShanghai Jinkui Medical Devices Co., Ltd.("Jinkui Medical" for short)Jinkui Medical"") Application forBiodegradable Atrial Septal Defect Occluder。

Following August 2024,Shanghai Shape Memory Alloy Materials Co., Ltd., a subsidiary of MicroPort CardioFlow Medtech CorporationIndependently DevelopedMemoSorb^®Biodegradable Atrial Septal Defect OccluderApproved for registration by the National Medical Products Administration (NMPA), becomingThe World's First Biodegradable Occluder Independently Developed in China, marking a significant breakthrough in China's biodegradable field of interventional treatment for structural heart disease, Jinkui Medical's newly submitted biodegradable atrial septal defect occluder has officially entered the innovation channel, which is expected to further enhance China's independent and high-end innovation landscape in this field.

# Research and Development Background

ButTraditional Metal OccluderAfter implantation, it will accompany the patient for life and may cause complications such as nickel ion release, endocardial tissue erosion, thrombosis, and atrial arrhythmias, and will also obstruct the subsequent interventional pathway of the left heart system.

Benefiting from the rapid development of biomaterials,Biodegradable OccluderSuccessively emerged, bringing hope for solving the problem of long-term retention of occluders in the body.

# PublicProduct Introduction of Jinkui MedicalShao

1. PansyBiodegradable PFO Occluder

▲Pansy Biodegradable Occluder

Pansy Biodegradable PFO Occluder is aPaymentSelf-expanding biodegradable occluder,Improved in terms of shapeability, resilience, and support; good biocompatibility, harmless degradation products, and reasonable cycle absorption.，CurrentlyA prospective, multi-center clinical trial study has been completed.。

The product adoptsSingle-Rivet Double-Disk Self-Expanding Mesh Structure, the mesh is gradually absorbed by the body during the repair process,Finally degraded into small molecules that are harmless to the human body and excreted., leaving no metal implants in the heart and avoiding associated long-term risks.

Working Principle

The occluder is placed at the defect site through a delivery device, blocking blood flow through the foramen ovale to achieve the therapeutic purpose. The main mesh structure made of degradable material provides sufficient support for the repair of the defect area, and this component gradually degrades during the repair process.The final degradation products are water and carbon dioxide., and the defect area was eventually fully repaired by autologous tissue.

Product Features

• Good Restorability, which can automatically return to its preset shape after passing through the delivery device.；

• Sufficient support, which can firmly clamp after release without displacement or falling off.；

• Single rivet structureCan avoid thrombosis and mechanical injury；

• Before the tissue completes climbing, it hasSufficient Strength；

• Good Biocompatibility, and its degradation products are harmless to the human body.；

• Absorbed and metabolized by the human body within a reasonable period。

2. Mallow^®Single-Rivet Atrial Septal Defect Occluder

The product isChina's First Single-Rivet Self-Expanding Congenital Heart Disease OccluderIt is a封堵器 implanted through percutaneous transcatheter or transthoracic approach, and has obtained a monofilament braiding patent. With complete specifications, it is suitable for interventional treatment of various types of atrial septal defects.

Product Features

• First Single-Rivet Self-Expanding Design:With a monofilament weaving patent, the left disc has no stainless steel rivets, reducing the amount of metal implantation.

• Flexible and strong support:The mesh has ultra-high resilience, with a phase transition temperature of 32°C, and its support strengthens after release in the body.

• Shorter release spacing within the heart chambers:50% shorter than the double-rivet occluder, which improves the safety of intracavitary release.

• Immediate Occlusion, MRI Worry-Free:The surface is treated with an oxidation process, allowing immediate MRI 3.0T detection post-surgery.

• Perfect fit, easier endothelialization:The edge of the umbrella fits better with the tissue, which is more conducive to the climbing of epidermal cells and more complete endothelialization.

1. LifeTech Scientific

Lifetech Scientific has multiple atrial septal defect occluders., generally composed of a support network, end cap, plug head, flow-blocking membrane, and suture thread. Used for interventional treatment of atrial septal defects via percutaneous puncture, with femoral vein access.Among them,Ceramic Membrane Atrial Septal Defect OcclusionDouble-disc mesh structure, with all metal surfaces coated with titanium nitride film; the support mesh is made of nickel-titanium alloy, used for interventional treatment of atrial septal defect in congenital heart disease.

In 2010, Lifetech Scientific partnered with Professor Zhang Zhiwei, Deputy Director of Guangdong Cardiovascular Institute, to conductAbsnow Biodegradable Atrial Septal Defect OccluderThe research and development. The product isThe World's First Absorbable Atrial Septal Defect Occluder to Enter Formal Registration Clinical TrialsIn March 2019, the product successfully passed the NMPA's Special Review Procedure for Innovative Medical Devices. In June of the same year, the system was granted designation as a Humanitarian Use Device for rare diseases by the US FDA. Multi-center clinical trials are currently underway.

▲Absnow Absorbable Atrial Septal Defect Occluder

2. Shanghai Shape Memory Alloy Materials Co., Ltd.

The company also has several atrial septal defect occluders, includingMemoSorb^®Fully Degradable Occluder,Oxidation Film Single-Rivet Atrial Septal Defect Occluder, etc.

In August 2024, a team led by Professor Pan Xiangbin from the National Regional Medical Center at Fuwai Yunnan Cardiovascular Hospital, in collaboration with a team led by Professor Wang Yunbing from the National Engineering Research Center for Biomaterials, and Xintai Medical jointly developedThe World's First Biodegradable Occluder Independently Developed in China——MemoSorb^®BiodegradableSolutionAtrial Septal Defect OccluderApproved for marketing by NMPA.

As an important achievement under China's "medical-engineering integration" innovation mechanism, MemoSorb^®The bio-degradable occluder adopts an innovative design, breaking through the limitations of traditional metal occluders:

(1) Adopting a patented parachute locking design and double-disc internal clasp setting to ensure effective gripping and stable fastening, reduce the risk of detachment, and guarantee secure occlusion.

(2) The single-rivet concave and triangular hidden waist design provides stable conditions for cell deposition and tissue regeneration, accelerating autologous repair and healing.

(3) Compared with nickel-titanium alloy, the biocompatibility of biodegradable polydioxanone material is better, reducing inflammatory response, alleviating fibrosis, and promoting endothelialization.

(4) After the occluder degrades, the atrial septum is remodeled, preserving tissue elasticity and not affecting subsequent trans-septal interventional treatment pathways, which is more beneficial for the patient's long-term health.

Related Reading:Approved for Marketing! The First Biodegradable Atrial Septal Defect Occluder

▲MemoSorb^®BiologyBiodegradable Occluder

3. Beijing Huayi Shengjie Technology Co., Ltd.

Cardi-O-Fix Parylene-Coated Atrial Septal Defect OccluderAs the second-generation coated occluder approved for marketing by the SFDA, its safety and efficacy have been confirmed by prior clinical trials.The coating material, Parylene film, is recognized by the FDA as a Class VI polymer medical material., which features better biocompatibility, low permeability, chemical inertness, biocompatibility, and non-toxicity.

Animal experiments and clinical trials of human serological tests have shown that, compared with traditional nickel-titanium alloy occluders, the Parylene-coated occluder can effectively prevent the release of nickel ions from the occluder, reduce the plasma nickel ion concentration in patients after surgery, thereby decreasing the occurrence of adverse events such as metal allergies and metal toxicity associated with traditional non-coated occluders.

This novel coating occluder represents a developmental trend in congenital heart disease occluders.

4. Dongguan Kewei Medical Devices Co., Ltd.

Kowei Medical's Atrial Septal Defect Occluder consists of an occlusion mesh frame, flow restrictors, and a nut. The occlusion mesh frame is made of nickel-titanium alloy, and the flow restrictors are made of polyester (Dacron), used for interventional treatment of atrial septal defects.

5. Shanghai Pushi Medical Devices Co., Ltd.

Pruitt Medical's atrial septal defect occluder has a double-disc mesh structure, composed of a nitinol wire frame, stainless steel sleeve, sutures, and polyester film. It is suitable for the treatment of secundum atrial septal defects (type II holes) in congenital heart disease.

6. Xuzhou Yatai Technology Co., Ltd.

AP Tech's Atrial Septal Defect Occluder is suitable for central secondary hole type atrial septal defects.It is produced byHyperelastic nitinol wire woven into a mesh to form a double-disc structure deviceThe two disc surfaces are connected by a cylindrical waist, with the diameter of the waist matching the size of the defect. After the product is implanted, the two discs are fixed on both sides of the atrial septal defect, preventing displacement and detachment. Several medical occlusion membranes sutured onto the discs and waist enhance the closure effect.

Product Features

• Superelastic nickel-titanium alloy wire undergoes special process treatment to effectively prevent nickel ion release, exhibiting excellent biocompatibility and ensuring safer clinical use.

• Using physical kneading technology, it ensures firmness without breaking fibers, reduces the incidence of thrombosis, and minimizes surgical complications.

• Unique waist design ensures accurate positioning and easy control, improving the success rate of surgery.

• The double-disc design provides strong support, fits well with the defect site after implantation, and is not easy to fall off.

• Complete range of models, providing doctors with more options.

The imported products are mainly Abbott's two occluders:

Atrial Septal Defect Occluder AMPLATZER Septal OccluderUsed for closing secondary atrial septal defects (ASD) or for occluding fenestrations in patients who have undergone fenestrated Fontan surgery.

Multi-Fenestrated Atrial Septal Defect Occluder Amplatzer Multi-Fenestrated Septal Occluder-CribriformFor closure of multi-hole (sieve-like) atrial septal defects.

# Company Introduction

Jinkui MedicalFounded inIn 2003, it was established as a high-tech innovative enterprise specializing in the research, development, production, and sales of high-value consumables for cardiovascular interventions. Currently available for sale areSingle-Rivet Atrial Septal Defect Occluder, Single-Rivet Patent Ductus Arteriosus OccluderAll are首创 in China., further improving the clinical treatment outcomes for patients with structural heart disease. The company has formed partnerships with multiple clinical trial bases and research institutions in China, actively promoting the integrated development mechanism of industry, academia, and research.

As of now, the products approved for listing by Jinkui Medical are as follows:4Payment: Single-rivet atrial septal defect occluder, single-rivet patent ductus arteriosus occluder, and2A delivery device for cardiac defect occluders.