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百心安-B(02185.HK)IBERIS®RDN系统在瑞士完成市场准入及首例商业化手术
Ge Long Hui· 2025-10-23 11:43
Core Viewpoint - The announcement highlights the successful market entry and commercialization of the Iberis® RDN system by the company's subsidiary, Shanghai Antong Medical Technology Co., Ltd, in Switzerland, marking a significant milestone in the company's product development and market strategy [1] Group 1: Product Development - The Iberis® RDN system has completed market access and the first commercial procedure in Switzerland, performed at the University Hospital of Basel, with no reported complications or adverse events [1] - The Iberis® RDN system is the only renal denervation (RDN) product globally approved for both transradial access (TRA) and transfemoral access (TFA) methods, enhancing safety, efficacy, and cost-effectiveness [1] Group 2: Strategic Partnerships - The company has established a strategic partnership with Bosheng International Group for the commercialization of the Iberis® RDN system, covering multiple regions including the EU, Asia-Pacific, and Latin America [1] Group 3: Regulatory Approvals - The Iberis® RDN system received CE marking in Europe in 2016, indicating its compliance with health, safety, and environmental protection standards for products sold within the European Economic Area [1]