PCI优化全链路解决方案
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蓝帆医疗股份有限公司关于子公司冠状动脉刻痕球囊扩张导管获得中国NMPA注册的公告
Shang Hai Zheng Quan Bao· 2025-12-11 19:27
Core Viewpoint - The approval of the "Coronary Scoring Balloon Dilatation Catheter" by the National Medical Products Administration (NMPA) represents a significant advancement for the company in providing effective solutions for complex coronary artery diseases [1][2]. Product Information - The product, named "Star Scar," features a unique spiral triangular scoring wire that allows for 360° efficient pressure-focused dilation [1]. - It is the only coronary scoring balloon with up to four scoring wires, providing a larger scoring area and a rated burst pressure (RBP) of up to 20 atm, enhancing safety during expansion [1]. - The device is particularly advantageous for treating calcified and high-resistance complex lesions, offering a safer and more ideal choice for coronary intervention [1]. Impact on the Company - The successful approval of the Star Scar catheter not only provides a precise and efficient pre-dilation option for complex coronary artery lesions but also completes the strategic puzzle for the company's cardiovascular division in constructing a "PCI optimization full-link solution" [2]. - This development is expected to positively influence the company's operational growth by enabling a comprehensive solution for both simple and complex lesions in PCI treatments [2].