Cho Jae-Sung, Haider Shan-E-Ali, Makaroun Michel S
Division of Vascular Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.
Semin Vasc Surg. 2006 Mar;19(1):18-24. doi: 10.1053/j.semvascsurg.2005.11.004.
Although many thoracic endografts are commercially available in Europe, only three such devices have been introduced to the United States. Gore TAG endoprosthesis was the first to enter clinical trials in the United States for treatment of descending thoracic aortic aneurysm, and gained the approval of the US Food and Drug Administration for general use in March 2005. Through clinical trials, the safety and efficacy of the Gore TAG endoprosthesis were proven and shown to be superior to those of open surgical repair. This article details the device and results of these trials.
尽管在欧洲有许多胸主动脉腔内移植物在市场上销售，但只有三种此类装置被引入美国。戈尔TAG腔内血管移植物是首个在美国进入治疗降主动脉瘤临床试验的产品，并于2005年3月获得美国食品药品监督管理局的全面使用批准。通过临床试验，戈尔TAG腔内血管移植物的安全性和有效性得到了证实，且显示优于开放性手术修复。本文详细介绍了该装置及其试验结果。
