Lifetech Scientific Corporation Discloses Two New Patents for Cardiac Occluders

Recently, two patents of Lifetech Scientific, a leading domestic manufacturer of occluders, have entered the public disclosure stage, including one for a left atrial appendage occluder and another for an occluder and its preparation method.

Lifetech Scientific, established in 1999, is a well-established innovative enterprise in China’s high-value medical device consumables sector. The company has developed a comprehensive product portfolio in the fields of peripheral vascular disease, structural heart disease, and bradycardia, and has achieved sales coverage in more than 100 countries and regions worldwide.

The newly disclosed patents are primarily aimed at enhancing the performance of occluders.. Among them, the novel left atrial appendage (LAA) occluder can contract and relax with cardiac motion, effectively distributing the stress caused by LAA deformation at its opening, thereby ensuring close apposition to the inner wall of the LAA after implantation; meanwhile, another novel occluder can prevent or reduce the risk of occlusion failure due to loss of mechanical properties during degradation before endothelialization occurs.

According to the 2023 annual results announced by Lifetech Scientific, the products provided by its structural heart disease business mainly include left atrial appendage occluders and congenital heart disease occluders. During the reporting period, sales revenue amounted to approximately RMB 495.7 million, representing a year-on-year increase of about 25.6%.

Among these, revenue generated from the sales of left atrial appendage occluders increased by approximately 32.0% year-on-year; revenue generated from the sales of congenital heart disease occluders increased by approximately 23.1% year-on-year.Lifetech Scientific’s structural heart disease business features a diversified product portfolio, continuously meeting growing treatment demands through sustained technological innovation and product upgrades.。

Lifetech Scientific’s Structural Heart Disease Business. Image source: Company official website

For example, the first-generation HeartR series, based on nitinol, is priced at a lower level and continues to experience growth. The company will actively expand into lower-tier channels in the future, targeting domestic lower-tier markets and economically less developed regions such as Southeast Asia. The second-generation Cera series incorporates a bioceramic coating of nano-titanium nitride to improve biocompatibility and accelerate endothelialization. Its share of revenue has been steadily increasing, with the product upgrade partially replacing the HeartR series. Since its launch in 2019, sales have amounted to approximately RMB 80 million.

Subsequently, Lifetech Scientific made rapid strides in the field of cardiac occluders, achieving remarkable results.Lifetech Scientific has successively deployed the Absnow™ device and the IrisFit PFO occluder for innovative materials.Among them, the Absnow™ device is a fully biodegradable septal occluder featuring a double-disc poly-L-lactic acid (PLLA) framework and an integrated PLLA membrane to ensure its biodegradability, clinical safety, and efficacy.

From the perspective of overall competition, an oligopolistic competitive landscape has basically taken shape in China's cardiac occluder market.. In 2021, domestic manufacturers held approximately 91.5% of the market share, with key players including Shanghai Shape Memory Alloy Material Co., Ltd., Lifetech Scientific, and Huayi Shengjie, while the remaining 8.5% was accounted for by international manufacturers of congenital heart disease occluders.

On the other hand, the research, development, and manufacturing of cardiac occluders require substantial capital investment, demand advanced technical expertise, and present high entry barriers, thereby limiting the ability of start-ups to catch up.However, there is still room for substitution in niche segments.。

For example, the market for left atrial appendage (LAA) occluders used in the treatment of cardioembolic stroke is expanding rapidly and holds substantial growth potential. According to Frost & Sullivan, the domestic LAA occluder market in China was valued at RMB 500 million in 2021, with a compound annual growth rate (CAGR) of 69.9% from 2017 to 2021. The CAGR is projected to be 43.2% from 2021 to 2025, reaching a market size of RMB 2.1 billion by 2025.

From the perspective of domestic market share, the left atrial appendage (LAA) occluder market is highly concentrated, with the imported brand Boston Scientific holding the majority share. According to data from the 2022 "China Medical Device Blue Book," Boston Scientific accounted for 67% of China's LAA occluder market, while the domestic brand Lifetech Scientific held a 25% market share. In order to capture market share, Currently, the research and development of left atrial appendage closure devices has entered a stage of vigorous competition, with several such devices already approved for market launch.

Mainstream Domestic Left Atrial Appendage Occluders

In 2016, Lifetech Scientific’s LAmbre™ Left Atrial Appendage Occluder System became the first to receive CE certification from the European Union. It obtained registration approval from China’s National Medical Products Administration (NMPA) in 2017, marking it as the first commercially launched left atrial appendage occluder system independently developed in China. In 2017, the LAmbre™ system generated sales revenue of approximately RMB 21.1 million.

On January 5, 2024, the AnchorMan® Left Atrial Appendage Occluder System, developed by MicroPort CardioFlow Medtech, received approval from the National Medical Products Administration (NMPA) for market launch, becoming the only approved semi-occlusive left atrial appendage occluder product in China. The accompanying AnchorMan® Left Atrial Appendage Delivery System had already been approved in October 2023.

Among them, the AnchorMan® Left Atrial Appendage Occluder System consists of a left atrial appendage occluder and a delivery system. It is indicated for patients with non-valvular atrial fibrillation who have a CHA₂DS₂-VASc stroke risk score ≥ 2 and have contraindications to long-term oral anticoagulation therapy or remain at risk of stroke despite anticoagulation therapy.

Driven by emerging technologies, favorable policies, and an aging population, the field is poised for new development. With the rise of more innovative enterprises, research in the left atrial appendage (LAA) occluder sector is expected to achieve new breakthroughs, ending China’s reliance on imported products and breaking the import monopoly in this area.