MARC details
| 000 -LEADER |
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| fixed length control field |
04367nam a22006497a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
170411s20162016 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
1936-8798 |
| 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 |
27609249 |
| 245 ## - TITLE STATEMENT |
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| Title |
Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System. |
| 251 ## - Source |
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| Source |
Jacc: Cardiovascular Interventions. 9(17):1757-64, 2016 Sep 12 |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
JACC Cardiovasc Interv. 9(17):1757-64, 2016 Sep 12 |
| 253 ## - Journal Name |
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| Journal name |
JACC. Cardiovascular interventions |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2016 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2017 |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2017-05-24 |
| 501 ## - WITH NOTE |
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| Local holdings |
Available online through MWHC library: 2008 - present |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
BACKGROUND: The Absorb BVS System is a first-of-its-kind fully bioresorbable percutaneous coronary intervention technology. The absorb BVS was studied in the ABSORB III (A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions) trial, the pivotal U.S. investigational device exemption trial. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
CONCLUSIONS: Following panel discussions and the evidence presented, the panel voted for approval of the device. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
Copyright c 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
METHODS: Observational report of the FDA Circulatory System Device Panel pre-market approval application meeting held on March 15, 2016. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
OBJECTIVES: This study aims to describe the discussions and recommendations made during the U.S. Food and Drug Administration (FDA) Circulatory System Device Panel pre-market approval application for the Absorb Bioresorbable Vascular Scaffold (BVS) System. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
RESULTS: The U.S. FDA Circulatory System Device Panel members reviewed the ABSROB III trial outcomes and additional post hoc analyses presented by the sponsor and the FDA. The ABSORB III trial met the primary endpoint of noninferiority of Absorb BVS compared with the control, XIENCE drug-eluting stent, for target lesion failure at 1 year. Although a higher numerical trend for adverse outcomes was reported for the Absorb BVS, there were no statistical differences between Absorb BVS and XIENCE for any safety or effectiveness components for target lesion failure or for the secondary pre-specified outcomes. Panel members raised concerns with regard to the ABSORB III results and post hoc analyses focusing mainly on the noninferiority design of the trial, the apparent safety issues of the Absorb BVS in small vessels, the mismatch of visually versus intravascular imaging assessed vessel size found in ABSORB III and its implications on the adequate device labeling, the safety of Absorb BVS in specific patient and lesion subsets, and the post-approval commitments of the sponsor. |
| 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 |
*Absorbable Implants |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Advisory Committees |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Cardiovascular Agents/ad [Administration & Dosage] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Coated Materials, Biocompatible |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Coronary Artery Disease/th [Therapy] |
| 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 |
*Everolimus/ad [Administration & Dosage] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Percutaneous Coronary Intervention/is [Instrumentation] |
| 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 |
Cardiovascular Agents/ae [Adverse Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Clinical Trials as Topic |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Coronary Artery Disease/dg [Diagnostic Imaging] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Equipment Safety |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Everolimus/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 |
Percutaneous Coronary Intervention/ae [Adverse Effects] |
| 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 |
Risk Assessment |
| 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 |
Rogers, Toby |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Steinvil, Arie |
| 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 |
Rogers T, Steinvil A, Torguson R, Waksman R |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1016/j.jcin.2016.06.027">https://dx.doi.org/10.1016/j.jcin.2016.06.027</a> |
| Public note |
https://dx.doi.org/10.1016/j.jcin.2016.06.027 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
