SINOMED(SH:688108) Xin Lang Cai Jing·2025-10-31 08:17Core Viewpoint - Sino Medical (688108.SH) has received approval from the Korean Ministry of Food and Drug Safety for its self-developed TRADENTTM coronary artery balloon dilation catheter, marking a significant milestone in its product portfolio expansion in overseas markets [1] Product Approval and Features - The TRADENTTM catheter is designed for the treatment of vascular stenosis during PTCA, featuring a unique "spiral" layout of thorn wires on the balloon surface, which enhances embedding capability while maintaining good passability [1] - Compared to existing plaque-modifying balloons in the market, this product offers more comprehensive plaque coverage and effectively reduces the incidence of dissection [1] Regulatory Approvals and Market Potential - The product has already obtained medical device registration certificates from the National Medical Products Administration of China, as well as from Thailand and Korea [1] - Following its launch in Korea, the product is expected to complement the company's coronary stents and balloons, potentially boosting overseas sales [1] Market Challenges - Sales in international markets may be influenced by uncertainties related to foreign regulations, market environment changes, and exchange rate fluctuations [1]