Preclinical testing for aortic endovascular grafts: Results of a Food and Drug Administration workshop

Journal of Vascular Surgery

Volumn 35, Issue 5, 2002, Pages 1022-1028

  Abel, Dorothy B ^a,g   Beebe, Hugh G ^b   Dedashtian, Mark M ^c   Morton, Michael C ^d   Moynahan, Megan ^a   Smith, Louis J ^e   Weinberg, Steven L ^f  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b JOBST VASCULAR CENTER   (United States)

^c EDWARDS LIFESCIENCES   (United States)

^d Alcon Research Ltd   (United States)

^e W L GORE AND ASSOCIATES   (United States)

^f Biomedical Device Consultants

^g CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABDOMINAL AORTA ANEURYSM; AORTA GRAFT; ARTICLE; ENDOVASCULAR SURGERY; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL; TREATMENT FAILURE; ANIMAL; BLOOD VESSEL PROSTHESIS; BLOOD VESSEL TRANSPLANTATION; DISEASE MODEL; REVIEW; SAFETY; STANDARD; UNITED STATES;

ANIMALS; AORTIC ANEURYSM, ABDOMINAL; BLOOD VESSEL PROSTHESIS; BLOOD VESSEL PROSTHESIS IMPLANTATION; DEVICE APPROVAL; DISEASE MODELS, ANIMAL; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0036581402     PISSN: 07415214     EISSN: None     Source Type: Journal    
DOI: 10.1067/mva.2002.123762     Document Type: Article

References (15)

1. Harris P, Brennan J, Martin J, et al. Longitudinal aneurysm shrinkage following endovascular aortic aneurysm repair: a source of intermediate and late complications. J Endovasc Surg 1999;6:11-6.
2. Wever JJ, Blankensteijn JD, Brooders IA, Eikelboom BC. Length measurements of the aorta after endovascular abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg 1999;18:481-6.
3. Umscheid T, Stelter WJ. Time-related alterations in shape, position, and structure of self-expanding, modular aortic stent-grafts: a 4-year, single-center follow-up. J Endovasc Surg 1999;6:17-32.
4. May J, White GH, Harris JP. Devices for aortic aneurysm repair. Surg Clin North Am 1999;79:307-27.
5. Resch T, Ivancev K, Brunkwall J, Nyman U, Malina M, Lindblad B. Distal migration of stent-grafts after endovascular repair of abdominal aortic aneurysms. J Vasc Interv Radiol 1999;10:257-64.
6. Beebe HG, Cronenwett JL, Katzen BT, Brewster DC, Green RM, for the Vanguard Endograft Trial Investigators. Results of an aortic endograft trial: impact of device failure beyond 12 months. J Vasc Surg 2001;33:S55-63.
7. Beebe HG. Late failures of devices used for endovascular treatment of abdominal aortic aneurysm: what have we learned and what is the task for the future? In: Gloviczki P, ed. Perspectives in vascular surgery and endovascular therapy. New York: Thieme; 2001. p. 29-49.
8. Abel D, Shulman M. The FDA and regulatory issues in graft development. Semin Vasc Surg 1999;12:74-82.
9. International Organization for Standardization. Cardiovascular implants: endovascular prostheses. ISO/TS 15539:2000. Stage date, October 26, 2000.
10. Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal aortic ancurysms. Ann Vasc Surg 1991;5:491-9.
11. Baum RA, Shetty SK, Carpenter JP, et al. Limb kinking in supported and unsupported abdominal aortic stent-grafts. J Vasc Interv Radiol 2000;11:1165-71.
12. Boyle JR, Thompson MM, Clode-Baker EG, et al. Torsion and kinking of unsupported aortic endografts: treatment by endovascular intervention. J Endovasc Surg 1998;5:216-21.
13. Krohg-Sorensen K, Brekke M, Drolsum A, Kvernebo K. Periprosthetic leak and rupture after endovascular repair of abdominal aortic aneurysm: the significance of device design for long-term results. J Vasc Surg 1999;29:1152-8.
14. Maleux G, Rousseau H, Otal P, Colombier D, Glock Y, Joffre F. Modular component separation and reperfusion of abdominal aortic aneurysm sac after endovascular repair of the abdominal aortic aneurysm: a case report. J Vasc Surg 1998;28:349-52.
15. Prinssen M, Wever JJ, Mali WP, Eikelboom BC, Blankenstcejn JD. Concerns for the durability of the proximal abdominal aortic aneurysm endograft fixation from a 2-year and 3-year longitudinal computed tomography angiography study. J Vasc Surg 2001;33:S64-9.