MARC details
| 000 -LEADER |
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| fixed length control field |
02827nam a22003857a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
221018s20222022 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
0895-7967 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1053/j.semvascsurg.2022.07.008 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
S0895-7967(22)00053-9 [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 |
36153078 |
| 245 ## - TITLE STATEMENT |
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| Title |
Regulatory challenges and investigational device exemption protocols for fenestrated and branched EVAR in the United States. [Review] |
| 251 ## - Source |
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| Source |
Seminars in Vascular Surgery. 35(3):374-379, 2022 Sep. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Semin Vasc Surg. 35(3):374-379, 2022 Sep. |
| 253 ## - Journal Name |
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| Journal name |
Seminars in vascular surgery |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2023 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Publication date |
2022 Sep |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
|---|
| Publication status |
ppublish |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Medline status |
In-Process |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2022-10-20 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
The US Food and Drug Administration (FDA) was created with the intent to ensure the safety of consumers in the United States. During the 1970s, this mandate was expanded to include medical devices. Aortic endografts, implanted since the 1990s, fall under this purview. Industry-sponsored and physician-sponsored investigation of the efficacy and safety of these devices is critical to the ongoing development of interventions for complex aortic anatomy. This research, in accordance with federal rules and regulation, must be conducted in coordination and with the approval of the FDA. The FDA has designed a process for which manufacturers or investigators may conduct efficacy and safety research using new or modified devices with oversight by the federal government. To conduct this type of research, an investigational device exemption must be obtained from the FDA. An investigational device exemption, although useful from a regulatory perspective, places a large time and financial responsibility on the investigator. As it stands now, the regulatory environment limits research into fenestrated and branched endovascular aortic repair to only those physicians and manufacturers able to provide the significant number of resources required to complete the laborious pre-application, application, and ongoing reports associated with obtaining and maintaining an investigational device exemption. Copyright © 2022. Published by Elsevier Inc. |
| 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 |
IN PROCESS -- NOT YET INDEXED |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Heart & Vascular Institute |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Washington Hospital Center |
| 656 ## - INDEX TERM--OCCUPATION |
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| Department |
Vascular Surgery Integrated Residency |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 657 ## - INDEX TERM--FUNCTION |
|---|
| Medline publication type |
Review |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Fatima, Javairiah |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| Local Authors |
Rossi, Matthew |
| Institution Code |
MWHC |
| Program |
Vascular Surgery Integrated Residency |
| Degree |
MD |
| Resident year |
Resident PGY 5 |
| 790 ## - Authors |
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| All authors |
Fatima J, Rossi MJ |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1053/j.semvascsurg.2022.07.008">https://dx.doi.org/10.1053/j.semvascsurg.2022.07.008</a> |
| Public note |
https://dx.doi.org/10.1053/j.semvascsurg.2022.07.008 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Journal Article |
| Item type description |
Article |
