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..

中国上海，2024年6月5日-最近，MicroPort®RotaPace的血管内压电导丝系统获得了NMPA的批准，可以进入创新医疗器械的特别审查程序（“绿色路径”）。该系统由复旦大学中山医院葛俊波院士领导的团队共同开发。。

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.

血管内压电导丝系统是一种一次性冠状动脉血管内冲击波导丝和治疗装置。它利用导丝技术中的压电效应，将机械振动传递到尖端，以突破并打开慢性完全闭塞（CTO）病变。

The device features adjustable vibration amplitude and frequency, assisting physicians in penetrating the hard, fibrous caps and calcified lesions within CTOs. .

该设备具有可调节的振幅和频率，可帮助医生穿透CTO内的坚硬，纤维帽和钙化病变。

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.

该系统目前正在进行临床试验，最近在中国大连对一名80岁男性进行了试验，该男性七年前在左前降支（LAD）动脉中植入了两个支架。在经历夜间呼吸困难后，他访问了大连医科大学第二附属医院。

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.

冠状动脉造影显示，他的两条血管变窄，LAD中以前的支架100%闭塞，伴有严重钙化。因此，在右冠状动脉近端植入支架后立即打开闭塞的LAD血管至关重要。鉴于闭塞的持续时间延长以及与严重钙化相关的复杂性和风险，赵欣教授的团队使用了血管内压电导丝系统。

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.' .

他解释说，“在这个过程中，通过精确的导管引导和产品的高频冲击，我们成功地穿透了闭塞病变的纤维帽，为随后的支架植入和血流恢复奠定了基础。”。

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.

作为共同开发者，葛院士表示：“在整个创新过程中，医生和工程师之间的密切合作至关重要。血管内压电导丝系统将创新概念转化为实用解决方案，通过硬钙化的CTO病变创建“隧道”，以帮助交叉闭塞。

We hope this will significantly benefit coronary heart disease patients and contribute to the global advancement of medical care.'.

我们希望这将大大有益于冠心病患者，并为全球医疗保健的进步做出贡献。”。

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®.

MicroPort®冠状动脉总裁Bin Yue博士表示，“为了克服慢性完全闭塞经皮冠状动脉介入治疗（CTO-PCI）的挑战，我们与葛院士，马建英教授等合作进行了无数的试验和探索。该认证标志着MicroPort®的第二个有源器件。

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.'

冠状动脉进入“绿色通道”未来，MicroPort®Coronary将继续推动技术创新，专注于高端创新医疗设备的开发，为冠心病提供高质量、便捷的解决方案。”

About MicroPort®

关于MicroPort®

RotaPace

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（上海MicroPort RotaPace MedTech Co.，Ltd.）成立于2020年，是MicroPort®Coronary（上海MicroPort Medical（Group）Co.，Ltd.）的关联公司，是一家创新的高端医疗器械公司，专注于全血管通路介入设备的研发，制造和商业化。

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”)..

MicroPort®RotaPace开创了心血管介入主动医疗设备的新途径，优先考虑复杂PCI手术和PCI后恢复的创新，以扩大其介入心血管治疗组合。其两种产品已被国家医疗产品管理局（NMPA）批准进入创新医疗器械特别审查程序（“绿色通道”）。。