Gore TAG Thoracic Endoprosthesis: the first US FDA-approved thoracic endograft.
Open surgical repair of thoracic aortic lesions carries a significant risk of complications, including death. Minimally invasive approaches, however, may improve outcomes. Clinical trials of the Gore TAG Thoracic Endoprosthesis device indicate that subjects receiving the graft are less likely to experience major adverse events, less intraprocedural blood loss, shorter intensive care unit and hospital stays, and reduced recovery times than surgical patients. The US FDA approved the device in March 2005. Since then, the device has been used widely, although a 0.30% rate of complications related to infolding or partial compression of the device prompted a 'Dear Doctor' letter in January 2006. This article profiles the TAG device and evaluates endografting technology in general.
Diethrich
Edward B
EB
Medical Director, Arizona Heart Institute and Arizona Heart Hospital, 2632 N. 20th Street, Phoenix, AZ 85006, USA. ediethrich@azheart.com
D001013:Aorta, Thoracic / Q000601:surgery; D017544:Aortic Aneurysm, Abdominal / Q000601:surgery; D001018:Aortic Diseases / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation; D006801:Humans; D019060:Minimally Invasive Surgical Procedures; D011474:Prosthesis Design; D014481:United States; D014486:United States Food and Drug Administration