MARC details
| 000 -LEADER |
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| fixed length control field |
03913nam a22006497a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
190521s20192019 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
1878-0938 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1016/j.carrev.2019.02.018 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
S1553-8389(19)30151-4 [pii] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
30879790 |
| 245 ## - TITLE STATEMENT |
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| Title |
Overview of the 2018 US Food and Drug Administration Circulatory System Devices Panel meeting on the INCRAFT AAA Stent Graft System. |
| 251 ## - Source |
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| Source |
Cardiovascular Revascularization Medicine. 20(5):403-408, 2019 05. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Cardiovasc Revasc Med. 20(5):403-408, 2019 05. |
| 252 ## - Abbreviated Source |
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| Former abbreviated source |
Cardiovasc Revasc Med. 20(5):403-408, 2019 May. |
| 253 ## - Journal Name |
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| Journal name |
Cardiovascular revascularization medicine : including molecular interventions |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2019 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2019 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
ppublish |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2019-05-21 |
| 268 ## - Previous citation |
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| -- |
Cardiovascular Revascularization Medicine. 20(5):403-408, 2019 May. |
| 501 ## - WITH NOTE |
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| Local holdings |
Available in print through MWHC library: 2002 - present |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
Copyright (c) 2019 Elsevier Inc. All rights reserved. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
On June 12, 2018, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to advise on the safety and effectiveness of the INCRAFT AAA Stent Graft System for the treatment of abdominal aortic aneurysms (AAA) and to consider a premarket approval application sponsored by Cordis, Inc., for Unique identifier: NCT01664078 based on the results of the pivotal INSPIRATION trial (URL: https://clinicaltrials.gov/ct2/show/NCT01664078). The INCRAFT AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies. The stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system, with the goal of isolating the aneurysmal sac and preventing sac rupture. The multicenter, prospective, non-randomized investigation trial met its primary composite safety and effectiveness endpoints but also showed higher-than-anticipated rates of stent fracture and endoleaks. The committee discussion focused on how these events impact the long-term safety and effectiveness, as well as the benefit/risk profile, of the device. While the panel acknowledged the risk of the device, the panel's final vote supported that the benefits of the INCRAFT AAA Stent Graft System outweigh the risks and that a post-marketing study should be mandated. The FDA approved the device for use in complex access anatomies in December 2018. |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Aortic Aneurysm, Abdominal/su [Surgery] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Blood Vessel Prosthesis |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Blood Vessel Prosthesis Implantation/is [Instrumentation] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Device Approval |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Endovascular Procedures/is [Instrumentation] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Stents |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*United States Food and Drug Administration |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aortic Aneurysm, Abdominal/dg [Diagnostic Imaging] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Blood Vessel Prosthesis Implantation/ae [Adverse Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Endoleak/et [Etiology] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Endovascular Procedures/ae [Adverse Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Evidence-Based Medicine |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Patient Safety |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Prosthesis Design |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Prosthesis Failure |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Risk Assessment |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Risk Factors |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Time Factors |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Treatment Outcome |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
United States |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Heart & Vascular Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Bernardo, Nelson L |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Buchanan, Kyle |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Iantorno, Micaela |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Torguson, Rebecca |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Waksman, Ron |
| 790 ## - Authors |
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| All authors |
Bernardo NL, Buchanan KD, Iantorno M, Torguson R, Waksman R |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1016/j.carrev.2019.02.018">https://dx.doi.org/10.1016/j.carrev.2019.02.018</a> |
| Public note |
https://dx.doi.org/10.1016/j.carrev.2019.02.018 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
