Zhitong Financial APP learned that the transcatheter aortic valve repair system-Leaflex aortic valve Performer (hereinafter referred to as "Leaflex valve") introduced by Qiming Medical-B (02500) completed its first human application in China on October 17th.
The application of this example was carried out successfully by Professor Dong Nianguo of Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, with the cooperation of Professor Wu Yongjian of Fuwai Hospital of Chinese Academy of Medical Sciences, Professor Peng Xiaoping and Professor Jiang Yu of the first affiliated Hospital of Nanchang University.
It is worth mentioning that the operation is also combined with the use of another innovative device of Qiming Medical, the TriGUARD3 antithrombotic distal brain protection device (hereinafter referred to as "TriGUARD3 brain"). This opens a precedent for the clinical use of China's first mechanized non-implanted heart valve calcification repair system and the first distal brain protective device.
The treatment achieved the desired effect, the patient's hemodynamics was stable, the whole repair process did not need to be carried out under the condition of pacing, and the aortic regurgitation was not aggravated after the repair. TEE showed that the peak flow velocity of the valve decreased by 37.4%, the peak pressure difference decreased by 58.9%, and the average pressure difference decreased by 56.4%. The innovative combination of TriGUARD3 drugs can effectively prevent embolic materials that may fall into the brain during the operation, reduce the risk of cerebral embolism, and further improve the safety of the operation. The patient recovered well after operation and was discharged on October 27.
Mr. Li Zhenjun, founder and General Manager of Qiming Medical, said, "Leaflex, as a cost-effective and durable independent treatment, can improve severe calcification of aortic valve and is expected to provide treatment options for more neglected and undertreated patients with aortic valve stenosis. The innovative combination of Leaflex "in conjunction with TriGUARD3" demonstrates Qiming Medical's persistence and courage in independent innovation. We will make continuous efforts to introduce innovative technologies into clinical application for the benefit of doctors and patients as soon as possible. "
The Leaflex valve is a unique mechanical device that can embosse the calcified part of the valve from multiple angles to break the calcium deposit, thus restoring the flexibility of the valve, improving the range of motion of the valve, and improving the hemodynamic index of the valve. For the repair of aortic valve calcification, only shock wave technology has been used in the world, but the relevant clinical results show that this technique is unstable in reducing the pressure difference and has not been put on the market so far. The emergence of Leaflex therapy provides a whole new treatment.
Leaflex valve was developed by Pi-Cardia Ltd. (Pi-Cardia), a global leader in non-implantable cardiac valve calcification solutions, and was introduced to China by Qiming Medical in September 2020. This repair technique can not only delay the TAVR of young patients who are not suitable for surgery, but also repair the aortic valve after several years of TAVR implantation, and achieve full-cycle coverage for patients with aortic valve stenosis at a cost lower than the cost of replacement, which is of great benefit to patients.
In Europe, the first human study of Leaflex legs has been completed in six clinical centers, demonstrating the function and safety of the device. Professor Eberhard Grube, an international pioneer in interventional therapy for valvular disease and a renowned expert at the University of Bonn Hospital in Germany, commented: "the Leaflex device has been proved to be very safe and effective in improving differential pressure and increasing valve area. It is expected to become a new generation of aortic valve repair device. "