Key result
Off-the-shelf TAMBE endograft finalizes pivotal trial for complex abdominal and thoracoabdominal aortic aneurysms.
Why the study?
Many fenestrated/branched endografts for complex abdominal and thoracoabdominal aortic aneurysms remain available only under physician sponsored investigational device exemption protocols in few US institutions.
The Gore Thoracoabdominal Branched Endoprosthesis (TAMBE) represents a promising off-the-shelf endovascular option for treating complex abdominal and thoracoabdominal aortic aneurysms.
Limited US availability of branched endografts under PSIDE protocols warrants expanded access; leaves open questions on widespread adoption for cAAA/TAAA.
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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Gomes et al. (2023) conducted a review in Complex abdominal (cAAA) and thoracoabdominal (TAAA) aortic aneurysms. Gore Thoracoabdominal Branched Endoprosthesis (TAMBE) was evaluated. The Gore Thoracoabdominal Branched Endoprosthesis (TAMBE) is a four-branched off-the-shelf endograft currently finalizing a pivotal trial for the treatment of complex abdominal and thoracoabdominal aortic aneurysms.
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