The COOK TX2 thoracic stent graft: preliminary experience and trial design.

Abstract:

: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.

journal_name

Semin Vasc Surg

authors

Hassoun HT,Matsumura JS

doi

10.1053/j.semvascsurg.2005.11.003

subject

Has Abstract

pub_date

2006-03-01 00:00:00

pages

32-9

issue

1

eissn

0895-7967

issn

1558-4518

pii

S0895-7967(05)00066-9

journal_volume

19

pub_type

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