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Cardiovascular Therapeutics: A Companion to Braunwald's Heart Disease
Volumn , Issue , 2007, Pages 67-75
The Process of Regulatory Review for New Cardiovascular Devices
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EID: 79955415936     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-1-4160-3358-5.50010-3     Document Type: Chapter
Times cited : (4)
References (14)
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    • Long-term use of a left ventricular assist device for end-stage heart failure
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    • Rose, E.A.1    Gelijns, A.C.2    Moskowitz, A.J.3
  • 5
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    • The role of clinical trials in the Food and Drug Administration approval process for cardiovascular devices
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    • FDA approval of coronary artery brachytherapy
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    • Propensity score analysis of stroke after off-pump coronary artery bypass grafting
    • Grunkemeier GL, Payne N, Jin R, et al. Propensity score analysis of stroke after off-pump coronary artery bypass grafting. Ann Thorac Surg 2002, 74:301-305.
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  • 8
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    • Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery
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    • Stone, G.W.1    Ellis, S.G.2    Cox, D.A.3
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    • Surrogate end points in clinical trials: Are we being misled?
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    • Considerations in the evaluation of surrogate endpoints in clinical trials: Summary of a National Institutes of Health Workshop
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    • Ensuring safe and effective medical devices
    • Feigal DW, Gardner SN, McClellan M Ensuring safe and effective medical devices. N Engl J Med 2003, 348(3):191-192.
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    • Muni, N.I.1    Gross, T.P.2

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.