抗胃食管反流系统是一款自主研发适用于括约肌磁性增强手术中治疗胃食管反流病的手术器械，括约肌 磁性增强手术旨在通过加强食管下括约肌的张力达到抗反流效果。 抗胃食管反流系统的工作原理是通过在食管外的食管下括约肌功能区域固定植入器械，植入器械的磁珠 产生磁吸引力加强食管下括约肌张力，从而恢复食管下括约肌的抗反流功能，治疗胃食管反流病。 康沣生物-B(06922)公布，于2025年12月15日，集团的抗胃食管反流系统，由植入式抗胃食管反流器及 食管测量工具组成，已获得国家药品监督管理局授出的批文。随着抗胃食管反流系统的获批，集团的产 品结构变得更加丰富且多样化。 ...

Core Viewpoint - Sino Medical's TRADENTTM coronary stent balloon dilation catheter has received approval from the Ministry of Food and Drug Safety (MFDS) in South Korea, marking a significant advancement in the treatment of coronary artery stenosis [1][2] Group 1: Product Approval and Features - The TRADENTTM catheter is the first of its kind in the domestic market to receive approval, specifically designed for percutaneous transluminal coronary angioplasty (PTCA) to treat vascular stenosis [1] - The product features a spiral layout of thorn wires on the balloon surface, enhancing its embedding capability while maintaining good passability [1] - The balloon can effectively lock onto calcified plaques and perform 360° plaque stripping, allowing for controlled and efficient pre-treatment [1] Group 2: Clinical Benefits - The approval of the TRADENTTM catheter is expected to improve the shortcomings of conventional balloon dilation catheters, increasing the success rate of lesion dilation [2] - It aims to reduce the risk of complications such as vascular perforation and damage to normal vessel walls, providing physicians with more clinical options [2] - Patients are anticipated to benefit from enhanced clinical outcomes due to the improved design and functionality of the catheter [2]