由于中期到后期研究结果呈阳性, FDA 延长了对 Humacyte 血管植入器 HAV 的审查. FDA extends review of Humacyte's blood vessel implant HAV due to positive mid- to late-stage study results.
美国食品药品监督管理局延长对Humacyte的人类血管植入物HAV的审查. FDA extends review of Humacyte's human blood vessel implant, HAV. 生物工程植入物是普遍的,抗感染,取代受损的血管。 The biologically engineered implant is universal and resistant to infection, replacing damaged blood vessels. 美国食品和药物管理局(FDA)延长审查是基于一项中后期研究,该研究显示,与合成植入物相比,HAV的血流率更高,感染率更低。 The FDA's extension of review was based on a mid- to late-stage study that showed HAV's higher rates of blood flow and lower infection rates compared to synthetic implants. Humacyte估计每年有10 000至30 000名美国病人因血管受伤。 Humacyte estimates that 10,000-30,000 US patients suffer from blood vessel injuries annually.