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

Seminars in Vascular Surgery
Heitham T Hassoun, Jon S Matsumura

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.

References

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Nov 8, 2005·Perspectives in Vascular Surgery and Endovascular Therapy·Heitham T HassounJon S Matsumura

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Citations

Sep 3, 2011·Herz·I AkinC A Nienaber
Mar 2, 2011·Seminars in Interventional Radiology·W Darrin Clouse
Jul 1, 2007·Future Cardiology·Stephan KischeChristoph A Nienaber
Apr 17, 2013·Der Internist·C A NienaberT Chatterjee
Oct 4, 2016·The Journal of Thoracic and Cardiovascular Surgery·Christoph A NienaberJohn Pepper
Jun 6, 2018·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Fiona RohlffsTilo Kölbel
Aug 31, 2007·Cardiology·Rabih A ChaerMalek G Massad
Oct 9, 2007·Current Opinion in Cardiology·William T BrinkmanJoseph E Bavaria
Jun 18, 2011·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Germano MelissanoRoberto Chiesa

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