获批CE!美敦力脉冲场消融导管双进展落地

心未来
Feb 06

白皮书+奖项+论坛|第二届全球心血管大会心未来近日,美敦力Medtronic宣布其Affera Sphere-360™ 脉冲场消融导管的两项重要进展:获得欧洲 CE 认证并顺利完成在美国的首批 IDE(研究性器械豁免)试验病例。这标志着该产品正式进入欧盟市场,同时迈出了在美国监管审批路径上的关键一步。# 研究背景房颤是心律失常领域最为常见的疾病之一,属于快速室上性心律失常,其显著特点是心房活动紊乱...

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