Evolution and future of preclinical testing for endovascular grafts

Journal of Endovascular Therapy

Volumn 13, Issue 5, 2006, Pages 649-659

  Abel, Dorothy B ^a,f   Dehdashtian, Mark M ^b   Rodger, Stuart T ^c   Smith, Angela C ^d   Smith, Louis J ^e   Waninger, Matthew S ^f  

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

^b EDWARDS LIFESCIENCES   (United States)

^c Vascutek   (United Kingdom)

^d W L GORE AND ASSOCIATES   (United States)

^e Cook Incorporated ^*  (United States)

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

Author keywords

Animal studies; Endovascular graft; Endovascular graft standards; Fixation; Food and Drug Administration; Material durability; Material fatigue; Preclinical testing; Sealing; Stent graft

Indexed keywords

ABDOMINAL AORTA ANEURYSM; ARTICLE; CORROSION; ENDOLEAK; ENDOPROSTHESIS; ENDOVASCULAR SURGERY; EVALUATION; FINITE ELEMENT ANALYSIS; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HISTOPATHOLOGY; MATERIALS TESTING; NONHUMAN; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; SHEEP; STENT; SWINE; SYSTEMATIC REVIEW; TENSILE STRENGTH;

ANIMALS; BLOOD VESSEL PROSTHESIS; DEVICE APPROVAL; MATERIALS TESTING; PROSTHESIS DESIGN; VASCULAR SURGICAL PROCEDURES;

EID: 33750967328     PISSN: 15266028     EISSN: None     Source Type: Journal    
DOI: 10.1583/06-1872.1     Document Type: Article

References (9)

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3. International Organization for Standardization Sterile, single use intravascular catheters - Part 2: Angiographic catheters. ISO 10555-2:1996.
4. International Organization for Standardization. Sterile, single use intravascular catheters - Part 4: Balloon dilatation catheters. ISO 10555-4: 1996.
5. Food and Drug Administration. Center for Devices and Radiological Health. Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, and Intravascular Stents. Rockville, MD: US Department of Health and Human Services. 1995.
6. Resch T, Ivancev K, Brunkwall J, et al. Distal migration of stent-grafts after endovascular repair of abdominal aortic aneurysms. J Vasc Interv Radiol. 1999;10:257-264.
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8. Beebe HG. Late failures of devices used for endovascular treatment of abdominal aortic aneurysm: what we have learned and what is the task for the future? In: Gloviczki P, ed. Perspectives in Vascular Surgery and Endovascular Therapy. New York: Theime; 2001:29-49.
9. Abel D, Beebe HG, Dedashtian M, et al. Workshop Steering Committee for the conference participants. Preclinical testing for aortic endovascular grafts: results of a Food and Drug Administration workshop. J Vasc Surg. 2002;35:1022-1028.