最新！又一款创新医疗器械获批

Group 1 - The PIONEER TAVR® system developed by CoKai (Nantong) Life Sciences has received approval from the National Medical Products Administration (NMPA) in China, marking a significant innovation in the field of interventional treatment for structural heart diseases [2] - The PIONEER TAVR® system provides a new treatment option for patients with severe aortic regurgitation (AR), particularly for those who are elderly or have other health issues that prevent them from undergoing traditional surgical procedures [2][5] - The system consists of three components: the aortic valve, the delivery system, and the valve loading device, designed specifically for high-risk AR patients [6][9] Group 2 - The PIONEER TAVR® system features innovative three-dimensional bending technology that allows for precise positioning and release during the procedure, ensuring optimal valve placement [8] - The system is designed for patients aged 70 and above with severe AR who cannot tolerate conventional surgery, offering a minimally invasive treatment alternative [8][10] - Clinical studies led by West China Hospital of Sichuan University involved 110 high-risk AR patients, demonstrating significant safety and efficacy of the PIONEER TAVR® system [10][12] Group 3 - The clinical study results showed a 99% technical success rate and a 97.27% device success rate within 30 days post-operation, with no moderate or severe paravalvular leaks reported [14] - One-year follow-up indicated an all-cause mortality rate of 2.7%, with no acute kidney injury or coronary artery obstruction observed, highlighting the system's advantages over traditional surgical methods [14][17] - The hemodynamic performance of the valve remained stable, with an effective orifice area of 2.05 cm² at one year, indicating long-term stability of the valve implantation [21] Group 4 - CoKai Life Sciences, established in 2018 and headquartered in Nantong, Jiangsu Province, focuses on innovative devices for treating structural heart diseases and aims to lead the domestic market while expanding globally [19] - The company has achieved significant breakthroughs in cardiac intervention, particularly in the development of transcatheter mitral valve repair systems and balloon dilation devices, showcasing strong technical innovation and market competitiveness [19]