MARC details
| 000 -LEADER |
|---|
| fixed length control field |
03937nam a22004097a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
130917s20122012 xxu||||| |||| 00| 0 eng dOvid Technologies |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
|---|
| International Standard Serial Number |
0003-4975 |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
|---|
| PMID |
23153481 |
| 245 ## - TITLE STATEMENT |
|---|
| Title |
Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States. [Review] |
| 251 ## - Source |
|---|
| Source |
Annals of Thoracic Surgery. 94(6):2147-58, 2012 Dec. |
| 252 ## - Abbreviated Source |
|---|
| Abbreviated source |
Ann Thorac Surg. 94(6):2147-58, 2012 Dec. |
| 253 ## - Journal Name |
|---|
| Journal name |
The Annals of thoracic surgery |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Year |
2012 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Manufacturer |
FY2013 |
| 266 ## - Date added to catalog |
|---|
| Date added to catalog |
2013-09-17 |
| 501 ## - WITH NOTE |
|---|
| Local holdings |
Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007 |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. Mechanical circulatory support has evolved to become an important therapy for patients who have advanced heart failure with the advent of more durable, implantable ventricular assist devices. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and Interagency Registry of Mechanically Assisted Circulatory Support. Copyright 2012 The Society of Thoracic Surgeons, American Heart Association, Inc, and International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved. |
| 546 ## - LANGUAGE NOTE |
|---|
| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Device Approval/st [Standards] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Heart Failure/th [Therapy] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Heart-Assist Devices/st [Standards] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Product Surveillance, Postmarketing/mt [Methods] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Registries |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Heart Transplantation/mt [Methods] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Heart Transplantation/st [Standards] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
United States |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
United States Food and Drug Administration |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
|---|
| Institution |
MedStar Heart & Vascular Institute |
| 657 ## - INDEX TERM--FUNCTION |
|---|
| Medline publication type |
Journal Article |
| 657 ## - INDEX TERM--FUNCTION |
|---|
| Medline publication type |
Review |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| Local Authors |
Boyce, Steven W |
| 790 ## - Authors |
|---|
| All authors |
Aaronson KD, Acker MA, Baldwin T, Blume E, Boyce S, Griffith B, Higgins R, Jessup M, Kormos R, Mack M, Mann DL, Miller L, Naftel D, Pagani FD, Rogers J, Slaughter MS, Starling RC, Stevenson L, Stough WG, Teuteberg J, Wearden P, Westaby S, Yancy C |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
|---|
| DOI |
<a href="http://dx.doi.org/10.1016/j.athoracsur.2012.09.040">http://dx.doi.org/10.1016/j.athoracsur.2012.09.040</a> |
| Public note |
http://dx.doi.org/10.1016/j.athoracsur.2012.09.040 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Journal Article |
| Item type description |
Article |
