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监管挑战加剧,波士顿科学退出全球心脏瓣膜业务
news flash· 2025-05-29 10:20
Core Viewpoint - Boston Scientific has announced its exit from the global heart valve business due to increasing regulatory approval challenges in various countries [1] Company Summary - Boston Scientific's transcatheter aortic valve replacement (TAVR) device, ACURATE neo2, received approval in China last year [1] - Industry experts indicate that Boston Scientific's TAVR product failed to meet the primary objective of being non-inferior to other already marketed TAVR devices [1] - The company stated that the resources required to meet regulatory approval requirements hindered further investment [1] Industry Summary - With Boston Scientific's exit, the main foreign competitors in the TAVR market in China are now limited to Edwards Lifesciences and Medtronic [1] - Domestic manufacturers hold a larger market share in the TAVR market in China following Boston Scientific's withdrawal [1]