医学
试验装置豁免
食品药品监督管理局
外科
多中心研究
现成的
腹部外科
腹主动脉瘤
普通外科
随机对照试验
医疗急救
动脉瘤
制造工程
工程类
作者
Vivian Carla Gomes,Mark A. Farber,F. Ezequiel Parodi
出处
期刊:Journal of Cardiovascular Surgery
[Edizioni Minerva Medica]
日期:2023-10-01
卷期号:64 (5)
被引量:2
标识
DOI:10.23736/s0021-9509.23.12717-0
摘要
The remarkable advances in technology and devices in the last two decades have made possible the endovascular repair of complex abdominal (cAAA) and thoracoabdominal (TAAA) aortic aneurysms with challenging anatomy. To date, despite the creation of multiple fenestrated/branched endografts intended to treat these difficult cases, in the USA, many of them remain available only under physician sponsored investigational device exemption (PSIDE) protocols in few institutions. The Gore Thoracoabdominal Branched Endoprosthesis (TAMBE; W.L. Gore & Associates, Flagstaff, AZ, USA) investigational device is a four-branched off-the-shelf (OTS) endograft that concluded an early feasibility study in 2016 and is currently finalizing a pivotal trial in pursuit of approval from the Food and Drug Administration. This article discusses the TAMBE early feasibility multicenter study results, the most relevant features of this device, its anatomical feasibility, and the impressions about this endograft as an OTS option for the treatment of CAAA and TAAA.
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