Journal of Vascular Surgery
Volume 34, Issue 1 , Pages 180-183 , July 2001

The Food and Drug Administration approval of endovascular grafts for abdominal aortic aneurysm: An 18-month retrospective

Received 18 April 2001 ,Accepted 18 April 2001.

References 

  1. Invited reviews. J Vasc Surg. 2001;33:S1–S84
  2. Informed Consent, 21 C.F.R., Food and Drugs (part 515) (2000).
  3. Summary of safety and effectiveness Ancure system. Food and Drug Administration, premarket approval decisions for. Available from: URL http://www.fda.gov/cdrh/pma/pmasep99 . htmlSeptember 1999;
  4. Summary of safety and effectiveness AneuRx. Food and Drug Administration, premarket approval decisions for. Available from: URL http://www.fda.gov/cdrh/pma/pmasep99.htmlSeptember 1999;
  5. FDA Modernization Act of 1997, amended 1998, Sect. 906. Washington: Govt. Printing Office; 1998;
  6. Harris P, Vallabhaneni PR, Desgranges P, Becquemin J-P, van Marrewijk C, Laheij PO-F, for the Eurostar Collaborators . Incidence and risk factors of late rupture, conversion, and death after endovascular repair of infrarenal aortic aneurysm. J Vasc Surg. 2000;32:739–741
  7. White RA, Donayre CE, Walot I, Woody J, Kim N, Kopchok GE. Computed tomography assessment of abdominal aortic aneurysm morphology after endograft exclusion. J Vasc Surg. 2001;33:S1–S10
  8. Bush RL, Lumsden AB, Dodson TF, Salam AH, Weiss VS, Smith RB, et al.  Midterm results after endovascular repair of abdominal aortic aneurysm. J Vasc Surg. 2001;33:571–576
  9. Johnston WK, Canadian Society for Vascular Surgery . Non-ruptured abdominal aortic aneurysm: six year follow-up of results from multicenter prospective Canadian aneurysm study. Aneurysm Study Group. J Vasc Surg. 1994;20:163–170
  10. Zarins CK, White RA, Fogarty TJ. Aneurysm rupture after endovascular repair using the AneuRx Stent Graft. J Vasc Surg. 2000;31:960–969

☆ Competition of interest: nil.

☆☆ The views expressed herein are those of the authors and do not necessarily reflect the views of the Food and Drug Administration.

★ J Vasc Surg 2001;34:180-3.

★★ Reprint requests: Wolf Sapirstein, MD, Food and Drug Administration, 9200 Corporate Blvd, Rockville, MD 20850 (e-mail: WYS@CDRH . FDA.GOV).

PII: S0741-5214(01)13747-X

doi: 10.1067/mva.2001.116440

Journal of Vascular Surgery
Volume 34, Issue 1 , Pages 180-183 , July 2001

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