MARC details
| 000 -LEADER |
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| fixed length control field |
02892nam a22004577a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
240807s20242024 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
0002-8703 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
S0002-8703(24)00126-1 [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 |
38815781 |
| 245 ## - TITLE STATEMENT |
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| Title |
Overview of 2024 FDA Advisory Panel Meeting on the TriClip transcatheter tricuspid valve repair system. |
| 251 ## - Source |
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| Source |
American Heart Journal. 275:21-34, 2024 May 29. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Am Heart J. 275:21-34, 2024 May 29. |
| 253 ## - Journal Name |
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| Journal name |
American heart journal |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2024 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2024 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Publication date |
2024 May 29 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
aheadofprint |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Medline status |
Publisher |
| 266 ## - Date added to catalog |
|---|
| Date added to catalog |
2024-08-07 |
| 266 ## - Date added to catalog |
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| Date Medline record created |
2024/05/30 19:21 |
| 501 ## - WITH NOTE |
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| Local holdings |
Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
Tricuspid regurgitation (TR) is common and associated with significant mortality and morbidity. Because the effectiveness and safety of medical and surgical treatments are limited, there is a significant unmet need for the treatment of this disease. Therefore, there is a growing market for percutaneous devices that offer safer, less invasive, and more effective treatment options in this patient population. On February 13, 2024, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to discuss the safety and effectiveness of the TriClip Transcatheter Valve Repair System (Abbott, Santa Clara, CA, USA). Several important points were discussed, including newly published data from the TRILUMINATE Pivotal study, the use of patient-oriented outcomes for device approval, and a discussion about training requirements and rollout plans when approving a breakthrough device. In this manuscript, we summarize the data presented by the sponsor and FDA and describe the deliberations and discussions during the meeting. Copyright © 2024 Elsevier Inc. All rights reserved. |
| 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 |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Indexing |
Automated |
| 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 |
|---|
| Department |
Advanced Cardiac Catheterization Research Fellowship |
| 656 ## - INDEX TERM--OCCUPATION |
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| Department |
Interventional Cardiology Fellowship |
| 657 ## - INDEX TERM--FUNCTION |
|---|
| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Ben-Dor, Itsik |
| Institution Code |
MHVI |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| Local Authors |
Chitturi, Kalyan |
| Institution Code |
MWHC |
| Program |
Advanced Cardiac Catheterization Research Fellowship |
| Degree |
DO |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| Local Authors |
Haberman, Dan |
| Institution Code |
MWHC |
| Program |
Interventional Cardiology Fellowship |
| Degree |
MD |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| Local Authors |
Lupu, Lior |
| Institution Code |
MWHC |
| Program |
Interventional Cardiology Fellowship |
| Degree |
MBA, MD |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| Local Authors |
Waksman, Ron |
| Institution Code |
MHVI |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| Local Authors |
Wermers, Jason P |
| Institution Code |
MHVI |
| 790 ## - Authors |
|---|
| All authors |
Lupu L, Haberman D, Chitturi KR, Wermers JP, Ben-Dor I, Waksman R |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1016/j.ahj.2024.05.011">https://dx.doi.org/10.1016/j.ahj.2024.05.011</a> |
| Public note |
https://dx.doi.org/10.1016/j.ahj.2024.05.011 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Journal Article |
| Item type description |
Article |
