MARC details
| 000 -LEADER |
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| fixed length control field |
02321nam a22003497a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
160113s20142014 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
1878-0938 |
| 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 |
25499024 |
| 245 ## - TITLE STATEMENT |
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| Title |
Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix drug coated balloon. |
| 251 ## - Source |
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| Source |
Cardiovascular Revascularization Medicine. 15(8):402-7, 2014 Nov-Dec. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Cardiovasc Revasc Med. 15(8):402-7, 2014 Nov-Dec. |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2016-01-13 |
| 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 |
The Lutonix drug coated balloon (DCB) is a combination device composed of a standard percutaneous angioplasty balloon coated with paclitaxel. Depending on the balloon size, a dose density of 2mug/mm(2) yields a variable total dose raging from 1.5mg to 3.8mg. This drug coated balloon aims to provide improved patency rates in patients with symptomatic femoropopliteal de novo or restenotic atherosclerotic disease. On June 12, 2014, the Food and Drug Administration's (FDA) Circulatory System Devices Panel reviewed the Lutonix DCB premarket approval application (PMA). This PMA application was primarily based on data from the pivotal randomized, controlled and multicenter clinical trial, which compared the Lutonix DCB with PTA. This summary aims to describe the discussions and recommendations made by the advisory panel during the meeting. Based on the Panel's recommendations, it is possible that the FDA will approve this device. Copyright � 2014 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 |
*Angioplasty, Balloon/is [Instrumentation] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Peripheral Arterial Disease/su [Surgery] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Vascular Access Devices |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Equipment Design |
| 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 |
Treatment Outcome |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
United States |
| 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 |
Vascular Access Devices/st [Standards] |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Heart & Vascular Institute |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Escarcega, Ricardo O |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Waksman, Ron |
| 790 ## - Authors |
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| All authors |
Escarcega RO, Waksman R |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="http://dx.doi.org/10.1016/j.carrev.2014.10.006">http://dx.doi.org/10.1016/j.carrev.2014.10.006</a> |
| Public note |
http://dx.doi.org/10.1016/j.carrev.2014.10.006 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Journal article |
