蓝帆医疗(002382.SZ):子公司冠状动脉刻痕球囊扩张导管获得中国NMPA注册

Core Viewpoint - Blue Sail Medical (002382.SZ) has received the medical device registration certificate from the National Medical Products Administration (NMPA) for its self-developed and produced Class III medical device, the "Coronary Scoring Balloon Dilatation Catheter" (branded as "Star Scar™") [1] Group 1: Product Features - The Star Scar™ catheter features a unique spiral-wound triangular scoring wire that allows for 360° efficient pressure-focused dilation [1] - It is the market's highest with four scoring wires, providing a larger scoring area and a rated burst pressure (RBP) of up to 20 atm, which offers a higher safety expansion margin [1] - The device excels in reducing the incidence of dissection and optimizing vascular preparation, particularly advantageous for complex lesions such as calcification [1] Group 2: Market Implications - The introduction of the Star Scar™ catheter provides a safer and more ideal option for coronary intervention treatments [1]