爱德华兹生命科学公司的Sapien 3 TAVR系统获得FDA批准, Edwards Lifesciences' Sapien 3 TAVR system gets FDA approval for early treatment of severe aortic stenosis.

爱德华兹生命科学公司的Sapien 3 TAVR系统已获得FDA批准用于治疗严重大动脉狭窄症无症状患者,这是首次获得此类批准. Edwards Lifesciences' Sapien 3 TAVR system has received FDA approval for treating asymptomatic patients with severe aortic stenosis, marking the first such approval. 根据EARLY TAVR试验,批准书表明,及早用TAVR治疗这些病人可以减少非计划住院的需要,而不是等待观察,而不会增加心血管病死亡率。 Based on the EARLY TAVR trial, the approval shows that treating these patients early with TAVR can reduce the need for unplanned hospitalizations compared to watchful waiting, without increasing cardiovascular mortality. 在将近4年的时间里,901名病人接受了审判。 The trial followed 901 patients over nearly 4 years.