Recently, MicroPort Xintong Medical Technology Co., Ltd. (02160.HK, hereinafter referred to as “MicroPort”), a subsidiary of MicroPort Medical Science Co., Ltd. (00853.HK, hereinafter referred to as “MicroPort Group”) 4C Medical Technologies, Inc. (“4C Medical”), an associate company of Xintong Medical, announced that its transcatheter mitral valve implantation device, AltaValve, has used its new generation of transatrial septal, low outer diameter, full The recyclable delivery system has completed the first human clinical applications through the humanitarian aid route. The two cases of transseptal mitral valve replacement were performed by Dr. Vlasis Ninio, Director of Cardiology at Interbalken Medical Center in Thessaloniki, Greece.
Two patients were diagnosed with severe mitral regurgitation requiring treatment to relieve symptoms of heart failure. However, neither of these two patients is suitable for surgery due to physical reasons, and because of their special cardiac anatomy, they are not suitable for other transcatheter mitral valve treatment options such as the transapical approach. Therefore, the transseptal mitral valve is Replacement surgery became the only hope. Mitral regurgitation symptoms were significantly reduced in both patients postoperatively, and cardiac function improved. At present, the patient has been discharged from the hospital, and the quality of life after surgery has improved significantly.
△AltaValve uses a unique supracircular valve device and atrial fixation design
Dr. Vlasis Ninio commented postoperatively: “We are proud to perform the AltaValve replacement using the next-generation transfemoral-transseptal access system for the first time in the world for two patients with no other treatment. Humanitarian relief surgery was successfully performed on selected patients. The AltaValve is simple to operate and can be applied to the wider mitral regurgitation patient population. The 4C Medical team not only provided us with excellent clinical training and support throughout the process, but also Dedicated to helping patients. The success of the surgery is inseparable from the efforts of the 4C Medical team.”
Transcatheter mitral valve replacement technology is very complex, and existing product solutions have many technical problems, including possible complications such as left ventricular outflow tract obstruction, impaired left ventricular function, and device embolism. , there is an urgent need for a product that can solve the above-mentioned clinical pain points and provide safer and more effective medical solutions for more patients. Most of the existing transcatheter mitral valve replacement systems adopt the “transapical approach” design, but this technique requires a transapical approach with an incision of about 3-5 cm in the patient’s left anterior chest, which is more traumatic. Another “transfemoral-transseptal approach” requires only a tiny incision in the patient’s groin, which is less traumatic and the patient recovers faster, but it requires more complicated intervention routes and is more difficult to develop. big.
As a “transfemoral-transseptal” transcatheter mitral valve replacement product, AltaValve uses a unique supra-annular valve device and atrial fixation design, and is expected to be available after the market. Become the world’s first mitral regurgitation treatment solution that can be fixed only in the atrium, thus avoiding the anchoring and fixation difficulties in the currently known TMVR technology to the greatest extent, and can minimize the risk of left ventricular outflow tract obstruction. risk, for more patients with mitral regurgitation. In addition, AltaValve is also the only known fully retractable transatrial septal valve system in the world that can achieve recovery function after complete release, enabling the operator to achieve more precise positioning and release during surgery.
△AltaValve implantation diagram
Dr. Saravana Kumar, Chairman and Chief Executive Officer of 4C Medical, said: “We are very excited about the clinical performance of the next-generation transseptal delivery system. 4C Medical is always committed to optimizing treatment options, and we will Continue to accumulate AltaValve’s large-scale evidence-based data to help more patients with severe mitral regurgitation. At the same time, 4C Medical will also continue to innovate in the field of structural heart disease, for the treatment of mitral and tricuspid regurgitation Streams offer more solutions.”
Mitral valve regurgitation is a common heart valve disease in which the patient’s mitral valve fails to close completely, causing some blood to flow back into the left atrium from the left ventricle during ventricular systole. Mitral regurgitation can cause the heart to enlarge and deform or to fail. In 2019, the number of patients with mitral regurgitation in the world was about 96.7 million, of which the number of patients in China accounted for nearly 1/9 of the total number of patients in the world, reaching 10.6 million. According to Frost & Sullivan, with the increasing global patient demand for transcatheter mitral valve repair/replacement products and the continuous emergence of more innovative technologies, it is estimated that by 2030, the global transcatheter mitral valve intervention therapy The market will be worth $17.4 billion, three to four times the size of the transcatheter aortic valve replacement market.
Xintong Medical President Mr. Chen Guoming said: “As an innovative medical device company focusing on the research and development of structural heart disease transcatheter treatment technology, 4C Medical’s research products cover the mitral valve. and the treatment of tricuspid regurgitation. In September 2018, Xintong Medical participated in the A round of financing of 4C Medical and obtained the exclusive commercial rights of its mitral valve products in China. In March 2021, Xintong Medical added The investment has become its largest shareholder, and at the same time, it has obtained the exclusive commercial rights of its tricuspid valve products under development in China, thus further enriching the product line and forming a more complete and diversified product portfolio. In the future, Xintong Medical We will continue to strengthen our cooperation to provide safer and more effective medical solutions for structural heart disease patients worldwide.”