EnVVeno 在美国 SAVVE 试验中展示了 VenoValve 的 11 个月积极顶线疗效数据。 EnVVeno presents positive 11-month topline efficacy data for VenoValve in SAVVE U.S. trial.
enVVeno Medical Corporation 公布了其在 SAVVE 美国进行的 VenoValve 关键试验的 11 个月积极顶线疗效数据，显示每位患者的平均修订静脉临床严重程度评分 (rVCSS) 总体改善率为 8.46。 enVVeno Medical Corporation presents positive 11-month topline efficacy data from its SAVVE U.S. pivotal trial for VenoValve, showing an overall 8.46 average Revised Venous Clinical Severity Score (rVCSS) improvement per patient. 72% 的研究患者表现出临床显著益处，而 94% 的患者在手术后 11 个月的加权平均时间内表现出临床改善。 72% of study patients showed clinical meaningful benefit, while 94% showed clinical improvement at a weighted average of 11 months post-surgery. 该公司预计将于 2024 年第四季度向 FDA 申请 VenoValve 批准。 The company is on track to file for VenoValve FDA approval in Q4 2024.