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Iberis多极肾动脉射频消融系统(Iberis RDN系统)
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百心安-B(02185):IBERIS® RDN系统在瑞士完成市场准入及首例商业化手术
智通财经网· 2025-10-23 11:53
Core Viewpoint - The announcement highlights the successful market entry and commercialization of the Iberis RDN system in Switzerland, marking a significant milestone for the company and its strategic partnership with 柏盛国际集团有限公司 [1] Group 1: Product Development and Approval - The Iberis RDN system, developed by the company's subsidiary 上海安通医疗科技有限公司, has completed market access and the first commercial procedure in Switzerland [1] - The 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] - The ultimate goal of the company is to provide outpatient RDN procedures for patients worldwide [1] Group 2: Strategic Partnerships - A strategic partnership has been established between 安通 and 柏盛 for the commercialization of the Iberis RDN system, covering multiple regions including the EU, Asia-Pacific, and Latin America [1] - The first commercial procedure was performed at 巴塞尔大学医院, with no reported complications or adverse events [1] Group 3: Regulatory Milestones - The Iberis RDN system received CE marking in Europe in 2016, indicating its compliance with health, safety, and environmental protection standards [1]