Xiangya Hospital's Chen Xiaobin Team Unveils Adjustable Cardiac Occluder with Published Patent

Professor Chen Xiaobin's team from Xiangya Hospital, Central South University submitted in March 2019A Patent for a Cardiac Occluder. This patent aims to address issues such as the deviation between the size of existing occluders and actual defects, and the high surgical risks, and entered the patent publication phase in May of the same year.

Figure shows a cardiac occluder, sourced from the patent specification.

Currently, occluders available in the market are mostly composed of three parts: a stainless steel sleeve, an occluder stent made of braided nickel-titanium alloy wires with shape memory function, and an obstructive membrane. Depending on different conditions and sizes of defects, the structural design and specifications of occluders also vary.

However, in actual use, the morphology of cardiac defects varies, while the specifications of occluders are generally fixed. The size of the occluders available for doctors to choose from usually deviates to some extent from the actual defect.For this reason, Professor Chen Xiaobin's team has developed a cardiac occluder that can be connected with adjustable components to move closer to each other.

At present, China is in the research and development innovation stage of cardiac occluders, with emerging...Lifetech Scientific, ScienTech Medical, and Starway Medical as representatives of innovative R&D enterprises, and these three companies form a tripartite dominance in China, occupying approximately 90% of the market share.

Firstly, in terms of the registration certificates obtained for cardiac occluder products, as of now, Lifetech Scientific (Shenzhen) Co., LTD. has received approval for 15 of its cardiac occluder products and related items; ScienTech Medical's related products have been approved with 14 certificates.

Data source: Lifetech Scientific（Shenzhen）Co.,LTD. official website

Looking at the细分领域 again, Lifetech Scientific's LAmbre™ Left Atrial Appendage Closure System received EU CE certification in 2016 and China NMPA registration approval in 2017, making it the first China-developed left atrial appendage closure system to be marketed. As of 2021, LAmbre™ has been widely used in over 40 countries and regions worldwide, with a cumulative total of 10,000 implants performed globally, capturing 25% of the market share in China.

In the field of biodegradable heart occluders, in February 2022, MemoSorb independently developed by ScienTech Medical^®Fully Degradable Occluder System Receives NMPA Approval for Market Launch; In the Same July, It Officially Embarks on the Clinical Application Journey; In September 2023, MemoSorb^®Biodegradable PFO Occluder Approved for Marketing and Officially Kicks Off Its Nationwide Clinical Application in October of the Same Year. As of now, MemoSorb^®Global Implant Volume of Biodegradable Occlusion Technology Breaks Through 1,000 Cases, with Clinical Application Safety and Effectiveness Fully Verified.

In order to encourage enterprises to develop occluders for congenital heart disease and promote the localization of medical devices, occluders for congenital heart disease have been included by the government in the Guiding Catalogue of Key Products and Services for Strategic Emerging Industries since 2013; In 2014, the government issued the "Notice on Printing and Distributing the National Key Supervision Medical Device Catalogue", which listed cardiac defect repair/occlusion devices within the national key supervision scope; In 2016, the government further guided the development of implantable products such as degradable occluders through the "Development Guidelines for the Pharmaceutical Industry"...

Encouraged by the policy, the entire industrial chain of cardiac occluders in China began to work together.。

China's Heart Occluder Industry Chain

From the perspective of upstream raw material suppliers in the industry chain, PerTech possesses core precision manufacturing processing capabilities such as nitinol material production, laser cutting, and laser welding, providing contract manufacturing services for the production and assembly of minimally invasive interventional device components like pacemakers and occluders.

From the perspective of research and development enterprises for occluders in the midstream of the industrial chain, major domestic companies are increasing their investment in the sector. In 2022, ScienTech Medical's expenditure on heart occluder development reached 19.4 million yuan, and in the first half of 2023, it amounted to 18.55 billion yuan. In the same year, Starway Medical's expenditure on patent foramen ovale occluder development reached 3.8 billion yuan, with nearly 2 billion yuan spent on R&D in the first half of 2023.

Besides,Collaboration between midstream enterprises and research institutions has also become another major way to update products.For example, the fully degradable cardiac occluder jointly developed by Shanghai Shape Memory, Professor Wang Yunbing's team from the National Engineering Research Center for Biomaterials at Sichuan University, and Fuwai Hospital became the world's only approved and marketed fully degradable cardiac occluder in 2022.