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Iberis®多极肾动脉射频消融导管系统(Iberis®RDN系统)
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百心安-B(02185.HK)IBERISRDN系统在英国注册
Ge Long Hui A P P· 2025-10-30 15:35
Core Viewpoint - The company announced that its subsidiary, Shanghai Antong Medical Technology Co., Ltd., has successfully registered the Iberis® RDN system with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) [1] Group 1: Product Development - The Iberis® RDN system is the only renal denervation (RDN) product globally approved for both transradial access (TRA) and transfemoral access (TFA) methods [1] - TRA enhances the safety, efficacy, and cost-effectiveness of RDN procedures [1] Group 2: Strategic Partnerships - The company has formed a strategic partnership with Bosheng International Group Limited to commercialize the Iberis® RDN system across multiple regions, including but not limited to EU countries, the Asia-Pacific region, and Latin America (LATAM) [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]