TY - JOUR
T1 - The COOK TX2 thoracic stent graft
T2 - Preliminary experience and trial design
AU - Hassoun, Heitham T.
AU - Matsumura, Jon S.
N1 - Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2006/3
Y1 - 2006/3
N2 - Endovascular treatment of thoracic aortic pathology (ETAP) has been under development for over a decade. Only recently has one device been approved in the United States for treatment of descending thoracic aortic aneurysms. The length of this development process is due to multiple device and deployment system modifications, as understanding has evolved of the unique challenges of reconstruction in the thoracic aorta. The TX2 system has evolved from pioneering custom-made designs into a mature system with several features designed to improve early and late results. Controlled trials are necessary to compare the outcomes of ETAP with standard open repair. This article will detail the current generation of the device, review large published single-center experiences, and describe an ongoing prospective, nonrandomized, multi-institutional, investigational device exemption (IDE) phase II pivotal clinical trial investigating the safety and effectiveness of this device in elective treatment of patients with descending thoracic aortic aneurysms.
AB - Endovascular treatment of thoracic aortic pathology (ETAP) has been under development for over a decade. Only recently has one device been approved in the United States for treatment of descending thoracic aortic aneurysms. The length of this development process is due to multiple device and deployment system modifications, as understanding has evolved of the unique challenges of reconstruction in the thoracic aorta. The TX2 system has evolved from pioneering custom-made designs into a mature system with several features designed to improve early and late results. Controlled trials are necessary to compare the outcomes of ETAP with standard open repair. This article will detail the current generation of the device, review large published single-center experiences, and describe an ongoing prospective, nonrandomized, multi-institutional, investigational device exemption (IDE) phase II pivotal clinical trial investigating the safety and effectiveness of this device in elective treatment of patients with descending thoracic aortic aneurysms.
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U2 - 10.1053/j.semvascsurg.2005.11.003
DO - 10.1053/j.semvascsurg.2005.11.003
M3 - Article
C2 - 16533690
AN - SCOPUS:33644915570
SN - 0895-7967
VL - 19
SP - 32
EP - 39
JO - Seminars in vascular surgery
JF - Seminars in vascular surgery
IS - 1
ER -