The COOK TX2 thoracic stent graft: preliminary experience and trial design.
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.
Department of Surgery, Division of Vascular and Endovascular Surgery, Johns Hopkins Hospital, Baltimore, MD, USA.
Heitham T
HT
Hassoun
Jon S
JS
Matsumura
D001013:Aorta, Thoracic / Q000473:pathology / Q000601:surgery*; D017545:Aortic Aneurysm, Thoracic / Q000473:pathology / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation; D002986:Clinical Trials as Topic; D015897:Comorbidity; D006801:Humans; D019060:Minimally Invasive Surgical Procedures; D015337:Multicenter Studies as Topic; D011091:Polyesters; D011474:Prosthesis Design; D012107:Research Design; D013193:Stainless Steel; D015607:Stents
D011091:Polyesters; D013193:Stainless Steel