Zhixin Medical Successfully Completes Preclinical Animal Trials for Its Innovative Transcatheter Mitral Valve Replacement System

Shanghai, March 2, 2022 /PRNewswire/ -- Recently, VAL VAID successfully completed the animal experiment of its self-developed transcatheter mitral valve replacement product at the Meifengli Animal Experiment Center in Taizhou. This experiment preliminarily verified the safety and efficacy of its mitral valve replacement product design, making full preparations for subsequent human clinical trials.

Group Photo of the Surgical Team

In total on the same dayCompletedFour Cases of Transcatheter Mitral Valve Replacement Product Animal ExperimentsThe founder and chief scientist of Taizhou Meifengli Animal Experiment Center, Wei Xufeng, led the team to perform a mitral valve replacement via transapical access on a living white pig. The surgery proceeded very smoothly, taking only two minutes from the transapical intervention to the final valve deployment. Post-surgery, echocardiography was used to evaluate the valve function, showing no significant paravalvular leakage, good valve mobility, minimal transvalvular pressure gradient, no valve regurgitation, and no obstruction of the left ventricular outflow tract. Left atrial pressure was also measured directly, with no significant increase observed. The surgical outcome received high recognition and praise from the surgical team.

Postoperative Angiography

Taizhou Meifengli Animal Experiment Center is a comprehensive large animal experiment center specializing in preclinical experimental research for medical devices, having accumulated extensive experience in preclinical large animal experiments in the field of medical devices, especially in cardiovascular areas. After the completion of the VAL VAID's transcatheter mitral valve preclinical animal trial this time,Wei Xufeng stated that compared with the multiple mitral valve replacement products already launched in the industry, VAL VAID has incorporated many innovative concepts into its product design, achieving a number of unique designs, thereby presenting many differentiated advantages in product performance. We look forward to VAL VAID's mitral valve replacement product entering clinical trials soon, benefiting a wide range of patients as early as possible.

Valvular heart disease is the "third leading cardiovascular disease" after coronary artery disease and hypertension, and mitral regurgitation is one of the most common valvular heart diseases. According to data from Zhongshan Hospital and the Second Affiliated Hospital of Zhejiang University in 2016, there are conservatively an estimated 10 million patients with mitral regurgitation in China, including 2 million patients with severe mitral regurgitation who require surgical intervention. Among them, 49% are high-risk patients intolerant to surgery, indicating a huge market potential for minimally invasive interventional treatments. However, currently, there are only a few products available from international pharmaceutical giants such as Abbott, leaving this field in China still largely unexplored.

As China's aging population intensifies and the incidence of heart valve disease rises,VAL VAID's animal trial of its mitral valve intervention product successfully completed, marking a solid step forward in the field of minimally invasive treatment for valvular diseases in China, and bringing significant benefits to numerous patients with valvular diseases.