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医疗器械研发与获批
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康沣生物-B:抗胃食管反流系统获得国家药监局批文
Zhi Tong Cai Jing· 2025-12-16 10:18
Core Viewpoint - The approval of the anti-reflux system by the National Medical Products Administration enhances the product portfolio of the company, making it more diverse and comprehensive [1] Group 1: Product Details - The anti-reflux system consists of an implanted anti-reflux device and esophageal measurement tools [1] - It is designed for use in magnetic enhancement surgery of the lower esophageal sphincter to treat gastroesophageal reflux disease [1] - The system works by implanting a device with magnetic beads in the functional area of the lower esophageal sphincter, which increases the tension of the sphincter to restore its anti-reflux function [1]
赛诺医疗:棘突球囊产品获得国外医疗器械注册证
Ge Long Hui· 2025-10-31 08:21
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]