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Another “Jiangbei-made” product has been approved for listing.

“In Germany, the tick mark is represented by the letter ‘X’ – it doesn’t mean negation, but rather ‘I’ve chosen it’. COR, in Latin, means ‘heart’. Xcor™, created for the heart.”
This is the latest post on the WeChat Moments of Ma Chenming, the chairman of Nanjing Shengde Medical Technology Co., Ltd. In just a few sentences, there lies a piece of good news:
Recently, the Xcor™ transcatheter aortic valve replacement system independently developed by the team has been approved for market launch by the National Medical Products Administration. In the field of interventional treatment of transcatheter aortic valves, clinicians and patients have once again been presented with a powerful domestic innovation option.

01
Aortic valve stenosis is a common heart valve disease among the elderly. In simple terms, it is the “valve” that is crucial for pumping blood from the heart to the rest of the body that has become narrowed, leading to symptoms such as breathing difficulties, angina pectoris, and fainting.
Transcatheter aortic valve replacement (TAVR) is an important minimally invasive interventional technique for treating aortic valve stenosis – by using a catheter to deliver an artificial valve through the blood vessels, allowing for the replacement of the aortic valve without the need for open-heart surgery. With the widespread adoption of TAVR surgeries, how to deal with complex anatomical structures and reduce postoperative complications has become the core focus of clinical attention.

The XCOR™ system that has been approved for market launch is providing solutions for these complex pathological conditions. Its greatest feature lies in its unique structural design.
It is described that, unlike most products on the market, XCOR™ is equivalent to equipping an artificial valve with “double insurance” – its self-expanding stent combined with a unique support arm can automatically “find its position” during the release process and form a longitudinal and radial dual anchoring with the patient’s native aortic valve. This “self-centering” design is like equipping the valve with a navigation system, which not only enables it to precisely locate in the direction of blood flow but also firmly fixes it, significantly reducing the risks of valve displacement or edge bleeding.
In addition, for some particularly challenging clinical situations, such as severe valve calcification, patients with a special structure of bicuspid aortic valve, or unsatisfactory vascular access conditions, XCOR™ has also demonstrated greater adaptability.
As early as 2022, this product completed its first implantation surgery in China. Subsequently, in clinical studies at authoritative centers such as West China Hospital, Xijing Hospital, and Guangdong Provincial People’s Hospital, XCOR™ has delivered an outstanding performance report. Clinical data have been published in international medical journals and domestic core journals, and have received recognition from multiple parties.

02


A “highly advanced” product has been approved for market launch, which will bring safer and more reliable treatment options to more patients. Behind this is the persistent effort of a team over several years.
As the founder of Shengde Medical, Ma Chenming once worked at the German National Cardiovascular Center – the German Heart Center. Seeing the hardships that many of his compatriots endured when seeking medical treatment far away, in 2019, he毅然decided to return to China to start a business, determined to develop heart valve products that are more suitable for the physical conditions of the Chinese people. Over the years, the team has been exploring in the field of heart valves, establishing technical barriers and moving forward continuously.
Now, this product has entered the market, but Ma Chenming and his team have not stopped their steps.

The success of TAVR surgery not only depends on excellent equipment, but also on precise preoperative planning. According to the relevant staff, Shengde Medical and its subsidiary Topmicro Heart are focusing on using artificial intelligence technology to empower the preoperative assessment of TAVR. A product called “CVPilot Intelligent Preoperative Assessment System” is also in the process of development.
It is known that this product combines advanced medical imaging technology with artificial intelligence algorithms. It can automatically segment and precisely measure the patient’s CTA images, from the circumference and area of the aortic valve ring, the height of the coronary artery opening, to the analysis of the volume of valve leaflet calcification… Every patient can have a comprehensive individualized assessment plan, providing precise basis for valve model selection and vascular access, etc.
In short, this system enables doctors to “anticipate” the surgical process before the operation and formulate the optimal strategy, thereby minimizing the surgical risks to the greatest extent and truly achieving the leap from “empirical medicine” to “precision medicine”.

The approval of the Xcor™ transcatheter aortic valve replacement system marks a solid step forward for Shengde Medical in the field of structural heart diseases. In the future, the team will continue to bring continuous technological innovation and intelligent diagnosis and treatment solutions to more patients with cardiovascular diseases, bringing hope and vitality to their lives.
Just as Ma Chenming wrote in his WeChat: Born for the heart. This is not merely a slogan; it is the most solemn commitment made by this group of entrepreneurs towards life.

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