Shanghai, China, 5 June 2024 — Recently, MicroPort® RotaPace’s Intravascular Piezoelectric Guidewire System gained NMPA approval for entry into the special review procedures for innovative medical devices (the “Green Path”). This system was co-developed by a team led by Academician Junbo Ge from Zhongshan Hospital, Fudan University.
The Intravascular Piezoelectric Guidewire System is a disposable coronary intravascular shock wave guidewire and treatment device. It leverages the piezoelectric effect in guidewire technology, transmitting mechanical vibrations to the tip to break through and open chronic total occlusion (CTO) lesions. The device features adjustable vibration amplitude and frequency, assisting physicians in penetrating the hard, fibrous caps and calcified lesions within CTOs.
The system is currently undergoing clinical trials, with a recent trial taking place in Dalian, China, on an 80-year-old male who had two stents implanted in his left anterior descending (LAD) artery seven years ago. He visited the Second Affiliated Hospital of Dalian Medical University after experiencing nocturnal dyspnea. Coronary angiography revealed that two of his blood vessels were narrowed, and the previous stents in the LAD were 100% occluded with severe calcification. Consequently, it was crucial to open the occluded LAD vessel immediately after a stent was implanted in the proximal right coronary artery. Given the prolonged duration of the occlusion and the complexity and risk associated with severe calcification, Professor Xin Zhao's team used the Intravascular Piezoelectric Guidewire system. He explained, "In this procedure, with precise catheter guidance and the high-frequency impact of the product, we successfully penetrated the fibrous cap of the occluded lesion, laying the foundation for subsequent stent implantation and restoration of blood flow."
As a co-developer, Academician Ge stated, “Close collaboration between physicians and engineers is essential throughout the innovation process. The Intravascular Piezoelectric Guidewire System transforms innovative concepts into practical solutions, creating 'tunnels' through hard calcified CTO lesions to aid in crossing occlusions. We hope this will significantly benefit coronary heart disease patients and contribute to the global advancement of medical care."
Dr Bin Yue, President of MicroPort® Coronary, remarked, "To overcome the challenge in chronic total occlusion percutaneous coronary intervention (CTO-PCI), we partnered with Academician Ge, professor Jianying Ma and others to conduct countless trials and explorations. This approval marks the second active device from MicroPort® Coronary to enter the 'Green Path.' In the future, MicroPort® Coronary will continue driving technological innovation, focusing on the development of high-end innovative medical devices to provide high-quality, accessible solutions for coronary heart disease."
About MicroPort® RotaPace
Founded in 2020, MicroPort® RotaPace (Shanghai MicroPort RotaPace MedTech Co., Ltd.), an associated company of MicroPort® Coronary (Shanghai MicroPort Medical (Group) Co., Ltd.), is an innovative high-end medical device company focusing on the R&D, manufacturing, and commercialization of panvascular access interventional devices. MicroPort® RotaPace pioneers new avenues in cardiovascular interventional active medical devices, prioritizing innovations for complex PCI surgeries and post-PCI recovery to expand its interventional cardiovascular treatment portfolio. Two of its products have already been approved by the National Medical Products Administration (NMPA) for entry into the special review procedures for innovative medical devices (“Green Path”).