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

Abel, David; Beebe, Hugh G.; Dedashtian, Mark M.; Morton, Michael C.; Moynahan, Megan; Smith, Loius J.; Weinberg, Steven L.

doi:10.1067/mva.2002.123762

Cited by 13 publications

(6 citation statements)

References 16 publications

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“…The abdominal aorta also exhibited shortening and twisting deformation from the supine to fetal positions. Abel et al 12 suggested that durability tests and stress analyses for longitudinal and torsional loading and bending were some of the most critical areas needing improvement.…”

Section: Discussionmentioning

confidence: 99%

“…10,11 Although government regulators have made significant efforts to improve preclinical evaluation of endovascular grafts, current testing protocols have not successfully predicted the aforementioned failure modes. 12,13 For designing preclinical tests, cardiac pulsation and respiratory motion have been the primary loading considerations in the form of pulsatile fatigue testing. On the other hand, static characteristics of the abdominal aorta, including the size and shape of the aortic neck, bifurcation divider offset, branch angle, and angular asymmetry, have been extensively investigated, since the geometry of the aorta is crucial for designing and implanting endovascular devices.…”

mentioning

confidence: 99%

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In Vivo Deformation of the Human Abdominal Aorta and Common Iliac Arteries With Hip and Knee Flexion:Implications for the Design of Stent-Grafts

Choi¹,

Shin²,

Taylor³

et al. 2009

Journal of Endovascular Therapy

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Although this study was limited to a few healthy young adults, musculoskeletal motion, specifically hip flexion, caused significant in vivo morphological changes (shortening, twisting, and bending) of the arteries. Predominant superior translation of the CIAs was observed, which suggests that preclinical testing of cyclic superior-inferior translational motion may aid in predicting stent-graft fractures. In turn, stent-graft design could be improved, decreasing overall stent-graft-related complications.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

In Vivo Deformation of the Human Abdominal Aorta and Common Iliac Arteries With Hip and Knee Flexion:Implications for the Design of Stent-Grafts

Choi¹,

Shin²,

Taylor³

et al. 2009

Journal of Endovascular Therapy

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“…The term "durability" has been used to describe the structural integrity of a device and its lasting ability to prevent the need for additional procedures. 21,22 Reporting these two issues separately is useful. The structural integrity of a device includes such events as stent fracture, fabric tears, and component separation.…”

Section: Data Collection and Analysismentioning

confidence: 99%

Reporting standards for adverse events after medical device use in the peripheral vascular system

Ouriel¹,

Fowl

Forbes

et al. 2013

Journal of Vascular Surgery

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“…Recognizing the need to improve preclinical testing, the FDA held a workshop in July 2001 attended by members of the medical device community involved in the development, testing, and use of EVGs. 9 The goal of the workshop was to define the physiological, anatomical, and morphological characteristics of abdominal aortic aneurysms (AAA) before and after EVG deployment and determine which characteristics should be considered during preclinical testing. Representatives of the EVG community agreed that there were significant limitations in testing and that the understanding of the in vivo environment was incomplete.…”

Section: First Workhop On Preclinical Testing Of Evgsmentioning

confidence: 99%

Evolution and Future of Preclinical Testing for Endovascular Grafts

Abel

Dehdashtian

Rodger

et al. 2006

Journal of Endovascular Therapy

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The preclinical testing of endovascular grafts has evolved significantly since the creation and early testing of these devices; however, there are continued limitations in using preclinical testing to predict clinical performance. Early testing was conducted in the absence of standards and guidance specific to endovascular grafts, and references available for vascular grafts and stents did not adequately account for the complexity of endovascular graft systems. Failure of early-generation devices suggested that the testing being conducted was inadequate and that there was a lack of understanding of the in vivo environment. These concerns led to several efforts to improve preclinical testing. The Food and Drug Administration (FDA) sponsored a workshop to discuss the limitations inherent in testing of endovascular grafts, and an ISO standard for endovascular grafts was developed. Publication of the standard in 2003 succeeded in standardizing testing and reporting across device manufacturers; however, several clinical failure modes, such as migration and stent fractures, continued to be unpredicted by current preclinical testing. This, coupled with knowledge gained from additional clinical experience, led the FDA to hold a second workshop to discuss the benefits and limitations of current testing and propose future testing that may better predict device performance. This workshop was successful in accurately describing past testing, determining what has been learned, identifying issues that have not been adequately addressed, proposing modifications to address these limitations, and discussing how the proposed modifications should be implemented. While significant progress has been made in endovascular graft testing, continued collaboration among industry, academia, regulators, and clinicians will provide continued improvement in the predictability of device performance.

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

Cited by 13 publications

References 16 publications

In Vivo Deformation of the Human Abdominal Aorta and Common Iliac Arteries With Hip and Knee Flexion:Implications for the Design of Stent-Grafts

In Vivo Deformation of the Human Abdominal Aorta and Common Iliac Arteries With Hip and Knee Flexion:Implications for the Design of Stent-Grafts

Reporting standards for adverse events after medical device use in the peripheral vascular system

Evolution and Future of Preclinical Testing for Endovascular Grafts

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