Domestic Interventional Consumables Innovate to Break Through: Igniting the Post-Volume-Based Procurement Era

Source: Medical Device Distributors Alliance

Editor: Jin Fan

Reproduction without authorization is prohibited, and reproduction is allowed 24 hours later!

Chinese-Made Biodegradable Occluder

Enter the "Green Channel" for Innovative Medical Devices

Recently (July 2, 2025), the official website of the Medical Device Technology Evaluation Center of the National Medical Products Administration announced a new batch of review results for special reviews of innovative medical device applications. A total of 14 products have entered the innovation channel, byShanghai Jinkui Medical Devices Co., Ltd. ("Jinkui Medical") independently developed a biodegradable atrial septal defect occluder product.Among them.

Atrial Septal Defect (ASD) is a relatively common type of congenital heart disease in clinical practice.Currently,Implantation of atrial septal occluder is the standard method for clinical treatment of ASD.。

However,Traditional heart occluders are mainly made of nickel-titanium alloy materials., which will permanently remain in the body after implantation. This not only poses risks of thrombosis and infective endocarditis but also creates obstructions for subsequent interventional treatments, causing the patient to lose the trans-septal interventional pathway.There is even a risk of having to undergo open-chest surgery again.

In view of this, it is imperative to promote the technological innovation in the field of cardiac occlusion interventional therapy to achieve the goal of "intervention without implantation, implantation without residue."

Since its establishment in 2003, Jinkui Medical has targeted the clinical demand for "green" treatment.Hand in HandThe First Affiliated Hospital of Xi'an Jiaotong University School of Medicine, General Hospital of Northern Theater Command of the Chinese People's Liberation Army, Shanghai International Medical Center for Children, Shanghai Changhai Hospital, etc.Top medical institutions in China have jointly conducted research in the field of degradable occluders and have been awarded support from the "National Natural Science Foundation" multiple times.

With the joint efforts of multiple parties and the support of national funding, Jinkui Medical has launchedPansy® BiodegradablePFOThe occluder has achieved a technological leap forward, using biodegradable materials as the base, innovative structural design as the guarantee, and long-term safety as the core requirement., leading China's cardiac occlusion interventional treatment into a new era of "green safety".

Professor Yushun Zhang from the First Affiliated Hospital of Xi'an Jiaotong UniversityOnce provided a clinically genuine use evaluation for pansy, further highlighting the clinical value of the product.

And on the basis of this breakthrough product,Mallow® Single-Rivet Atrial Septal Defect Occluder, the first self-expanding congenital heart disease occluder with a single rivet design in China., which not only owns the monofilament weaving patent, but also has no stainless steel rivets on the left disc, reducing the amount of metal implantation.The release distance within the cardiac chamber is reduced by 50% compared to the double rivet occluder., which improves the safety of intracavitary release. Meanwhile, the specifications are complete,Applicable for interventional treatment of various types of atrial septal defects.

As is known to all, the special review channel for innovative medical devices is commonly referred to as the "Green Channel."It is a fast-track channel established by the state for innovative medical device products with cutting-edge technology and urgent clinical needs. The latest industry report shows that the average time-to-market for medical device products passing through this channel can be reduced by 43%!

Focusing on the niche field of biodegradable ASD occluders, currently, there is only one product on the market in China: the MemoSorb® Biodegradable Atrial Septal Defect Occluder, which is independently developed by Shanghai Shape Memory Alloy Material Co., Ltd., a subsidiary of Shanghai Jinkui Medical Devices Co., Ltd.

Now, Jinkui Medical's biodegradable ASD occluder has successfully entered the special approval "green channel" for innovative medical devices, which means that its market launch process will be further expedited.Expected to become the second domestically produced degradable occluder approved in China`, bringing more high-quality and diverse new treatment options for patients with atrial septal defect (ASD) in China.`

However, in the context of the ongoing deepening of China's medical device industry's centralized procurement policy, China's ASD occluder market is undergoing an unprecedented transformation. In 2023, the Sanming Procurement Alliance included atrial septal defect occluders in the centralized procurement scope for the first time.The lowest proposed winning price was slashed to 4,896 yuan.The industry price system has been completely disrupted, which alsoDirectly leading to the compression of profit margins for traditional distributors.

Against this background,Finding new growth points in the track has become a must for all dealers.The drawbacks of traditional nickel-titanium alloy occluders implanted during surgery are becoming increasingly apparent."The 'biodegradable' technology has gradually become a key focus in clinical attention."

In China, a group of innovative medical device companies represented by Jinkui Medical have continuously overcome challenges and made breakthroughs in the field of "biodegradable" ASD occluder technology. These innovative achievements have not only injected new vitality into the market but also opened up highly promising strategic opportunities for distributors.

MemoSorb® was approved for marketing in August 2024.It is the first approved biodegradable atrial septal defect occluder product in China and globally.

It is made from novel biomedical polymer materials, featuring excellent biocompatibility, reduced inflammatory response, and accelerated endothelialization. It also employs a patented parachute locking design for effective clamping, providing mechanical compensation to ensure stable gripping of the occluder and prevent detachment. The dual-disk interlocking design ensures stable coupling, enhances surface support, and guarantees firm wall adherence and reliable stability.

As early as 2010, the R&D team of Lifetech Scientific collaborated with Professor Zhang Zhiwei, the deputy director of Guangdong Cardiovascular Institute, to develop a novel bioabsorbable atrial septal defect closure system, later known as the Absnow bioabsorbable atrial septal defect occluder.

This product is the world's first absorbable atrial septal defect occluder to enter formal registered clinical trials:In 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 U.S. FDA. Currently, multi-center clinical trials are underway.

At present, whether from the perspective of clinical needs or enterprises seeking a way out to deal with centralized procurement,"Biodegradable" implantable consumables are a highly promising and forward-looking new breakthrough direction.，The market and clinical feedback has also been positive.

Taking Lepu Xintai as an exampleAccording to publicly available information, as of March 2024, the company's MemoSorb® bioresorbable series occluders (namely, the MemoSorb® Fully Bioresorbable Occluder System and the MemoSorb® Bioresorbable Patent Foramen Ovale Occluder) products,The global implantation volume has successfully exceeded 1,000 cases.This remarkable achievement fully demonstrates the wide acceptance of degradable products in clinical applications, laying a solid foundation for market promotion and expansion.

At the same time, the outstanding performance of the product has also injected strong momentum into the company's performance growth. The world's first fully degradable occluder system for ventricular septal defect (VSD) treatment launched by the company in 2022, in 2023,The sales of this series of products achieved a year-on-year growth of 271%., becoming the flagship product in the field of congenital heart disease.

In 2023, the company's MemoSorb® Bioabsorbable PFO Occluder was launched. In the mid-term performance report of 2024, it was revealed thatThe revenue brought in accounted for nearly one-third of Jinkui Medical's total income and was the mainstay behind the 85.56% growth in Jinkui Medical's profits.

This series of impressive data performances strongly proves the significant commercial value of "biodegradable" consumables, which is a new trend in industry development. For distributors, actively deploying biodegradable consumables will become a key growth driver for seeking performance increase and exploring new market territories in the post-centralized procurement era.

Note:The above content is for reference only and does not constitute investment advice.The interpretation of official policies in this article only represents the views of this platform, and the content is subject to official documents. If any platform reprints this article, it must take responsibility for the article itself. The Medical Device Dealers Alliance is not responsible for the impact of secondary dissemination caused by reprints. Please contact the editor via the backend for reprinting.。