"In Germany, the checkmark is written as 'X' - not negative, but 'it's the one to choose.' cor, Latin, is 'heart'.Xcor™ for the heart."
This is the latest circle of friends of Ma Chenming, chairman of Nanjing Shengde Medical Technology Co., Ltd. in just a few words, hiding a good news:
Recently.Xcor™ Transcatheter Aortic Valve Replacement System developed by the team is approved for marketing by the National Drug Administration (NDA)TheIn the field of transcatheter aortic valve interventions, clinicians and patients have another powerful and innovative home-grown option.
01
Aortic stenosis is a common heart valve disease in the elderly. Simply put, it is a narrowing of the key "valve" through which the heart pumps blood throughout the body, leading to breathing difficulties, angina, fainting, and so on.
Transcatheter aortic valve replacement (TAVR) is an important minimally invasive interventional technique for the treatment of aortic stenosis - aortic valve replacement is achieved by transvascular delivery of a prosthetic valve through a catheter, without the need for open-heart surgery. With the popularity of TAVR, how to cope with the complex anatomical structure and reduce postoperative complications have become the core focus of clinical attention.
The XCOR™ system, which has been approved for marketing, provides a solution for these complex lesions. Its biggest highlight is hidden in its unique structural design.
Unlike most products on the market, XCOR™ is said to be equivalent to fitting a prosthetic valve with a"double insurance"--Its self-expanding stand with a unique support arm automatically "finds its place" during release.Dual longitudinal and radial anchoring with the patient's native aortic valveThis "self-centering" design is like a navigation device for the valve. This "self-centering" design is like a navigation device for the valve, which not only allows it to be precisely positioned in the direction of blood flow, but also holds it securely in place, greatly reducing the risk of valve displacement or marginal blood leakage.
In addition, for some particularly tricky clinical situations:For example, if the valve is particularly calcified, if the patient has the special configuration of a bileaflet aortic valve, or if the vascular access conditions are not optimal, XCOR™ has also shown to be more adaptable.
As early as 2022, this product completed the first implantation surgery in China. Subsequently, XCOR™ has delivered an eye-catching report card in the clinical studies of many authoritative centers, such as West China Hospital, Xijing Hospital, Guangdong Provincial People's Hospital, etc. The clinical data have been publicly published in international medical journals and domestic core journals, and have gained recognition from many parties.
02
The approval of a "hardcore" product will bring safer and more reliable treatment options to more patients. Behind this is the persistence of a team that has been working day in and day out for several years.
As the founder of Sundise Medical, Ma Chenming once worked in Germany's national cardiovascular disease center, the German Heart Center, because he has seen too many compatriots go far away to seek medical treatment, in 2019, he resolutely returned to China to start his own business, determined to research and development of heart valve products more suitable for the national physique. For several years, the team has been exploring heart valve-related fields, establishing technical barriers and moving forward.
Now that the product is on its way to the market, Ma Chenming and the team have not stopped.
"The success of the TAVR procedure.Not only do we rely on excellent instruments, but we also rely on precise preoperative planning.." Sundance Medical and its subsidiary, Topmicro Facsimile Heart, are focusing on empowering TAVR preoperative evaluation with AI technology, according to relevant staff.A product called "CVPilot Intelligent Preoperative Evaluation System" is also in progress.The
It is understood that this product combines advanced medical imaging technology and artificial intelligence algorithms, which can automatically segment and accurately measure the patient's CTA image, from the circumference and area of the aortic annulus, to the height of the coronary artery openings, and then to the valve leaflet calcification volume analysis ...... Each patient can have a full range of individualized assessment programs TheProvides accurate basis for valve type selection, vascular access, etc.The
In short, this system enables doctors to "anticipate" the surgical process before surgery and formulate optimal strategies to minimize the risk of surgery, thus truly realizing the leap from "empirical medicine" to "precision medicine". The system enables doctors to "anticipate" the surgical process before surgery and formulate optimal strategies to minimize surgical risks, thus truly realizing the leap from "empirical medicine" to "precision medicine.
The approval of Xcor™ Transcatheter Aortic Valve Replacement System is a solid step forward for Sundise Medical in the field of structural heart disease. In the future, the team will continue to bring the hope of life and the power of beating to more patients with cardiovascular diseases with continuous technological innovation and intelligent diagnostic and treatment solutions.
As Ma Chenming wrote in his circle of friends: Born for the heart. This is not only a slogan, but also this group of entrepreneurs, the most solemn commitment to life.
