HEALTH CARE REFORM Medical Device Regulatory Reform Insights From the Watchman Left Atrial Appendage Closure Technology for Stroke Prophylaxis in Atrial Fibrillation

被引:7
作者
Cingolani, Eugenio [1 ]
Stevens, Steven [1 ]
Shehata, Michael [1 ]
Diamond, George A. [1 ]
Kaul, Sanjay [1 ]
机构
[1] Cedars Sinai Med Ctr, Div Cardiol, Los Angeles, CA 90048 USA
关键词
CARDIOVASCULAR DEVICES; PREMARKET APPROVAL; FDA; FIBRILLATION; OCCLUSION; STRENGTH;
D O I
10.1001/archinternmed.2011.329
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
引用
收藏
页码:1670 / 1672
页数:3
相关论文
共 19 条
[1]   Regulation of devices [J].
Avorn, Jerry .
BRITISH MEDICAL JOURNAL, 2010, 341
[2]  
*CA HEALTHC I, UPC CHANG 510 K PROC
[3]   Statistics in the world of medical devices: The contrast with pharmaceuticals [J].
Campbell, Gregory .
JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2008, 18 (01) :4-19
[4]   Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices [J].
Dhruva, Sanket S. ;
Bero, Lisa A. ;
Redberg, Rita F. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2009, 302 (24) :2679-2685
[5]   Evidence-Based Financial Incentives for Healthcare Reform Putting It Together [J].
Diamond, George A. ;
Kaul, Sanjay .
CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES, 2009, 2 (02) :134-140
[6]   Modernizing Device Regulation. [J].
Garber, Alan M. .
NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (13) :1161-1163
[7]   SHATTUCK LECTURE Innovation, Regulation, and the FDA [J].
Hamburg, Margaret A. .
NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (23) :2228-2232
[8]   Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial [J].
Holmes, David R. ;
Reddy, Vivek Y. ;
Turi, Zoltan G. ;
Doshi, Shephal K. ;
Sievert, Horst ;
Buchbinder, Maurice ;
Mullin, Christopher M. ;
Sick, Peter .
LANCET, 2009, 374 (9689) :534-542
[9]   As time goes - Current status and future directions in the controversy over stenting [J].
Kaul, Sanjay ;
Shah, Prediman K. ;
Diamond, George A. .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2007, 50 (02) :128-137
[10]   Evidence Strength in FDA Premarket Approval of Cardiovascular Devices [J].
Kong, David F. ;
Hasselblad, Vic ;
Krucoff, Mitchell W. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 303 (16) :1599-1600