Chen E - Search Results

1

Cardiac safety research consortium "shock II" think tank report: Advancing practical approaches to generating evidence for the treatment of cardiogenic shock.

Samsky MD, Krucoff MW, Morrow DA, Abraham WT, Aguel F, Althouse AD, Chen E, Cigarroa JE, DeVore AD, Farb A, Gilchrist IC, Henry TD, Hochman JS, Kapur NK, Morrow V, Ohman EM, O'Neill WW, Piña IL, Proudfoot AG, Sapirstein JS, Seltzer JH, Senatore F, Shinnar M, Simonton CA, Tehrani BN, Thiele H, Truesdell AG, Waksman R, Rao SV. Samsky MD, et al. Among authors: chen e. Am Heart J. 2020 Dec;230:93-97. doi: 10.1016/j.ahj.2020.09.015. Epub 2020 Oct 2. Am Heart J. 2020. PMID: 33011148 Free PMC article. No abstract available.

2

A US Food and Drug Administration perspective on cardiac resynchronization and ventricular assist device trials.

Faris O, Chen E, Berman M, Moynahan M, Zuckerman B. Faris O, et al. Among authors: chen e. Congest Heart Fail. 2005 Jul-Aug;11(4):207-11. doi: 10.1111/j.1527-5299.2005.04620.x. Congest Heart Fail. 2005. PMID: 16106123 Free article. Review.

3

Pediatric circulatory support contractors' meeting: report of the Clinical Trials Working Group.

Webber S; Clinical Trials Working Group. Webber S, et al. ASAIO J. 2009 Jan-Feb;55(1):10-2. doi: 10.1097/MAT.0b013e318198e13d. ASAIO J. 2009. PMID: 19139653 Free PMC article. No abstract available.

4

Past, present, and future regulatory aspects of ventricular assist devices.

Patel-Raman SM, Chen EA. Patel-Raman SM, et al. J Cardiovasc Transl Res. 2010 Dec;3(6):600-3. doi: 10.1007/s12265-010-9225-3. Epub 2010 Oct 29. J Cardiovasc Transl Res. 2010. PMID: 21046301 Review.

5

US FDA perspective on regulatory issues affecting circulatory assist devices.

Sapirstein W, Chen E, Swain J, Zuckerman B. Sapirstein W, et al. Among authors: chen e. Expert Rev Med Devices. 2006 Nov;3(6):749-53. doi: 10.1586/17434440.3.6.749. Expert Rev Med Devices. 2006. PMID: 17280539

6

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

Almond CS, Chen EA, Berman MR, Less JR, Baldwin JT, Linde-Feucht SR, Hoke TR, Pearson GD, Jenkins K, Duncan BW, Zuckerman BD. Almond CS, et al. ASAIO J. 2007 Jan-Feb;53(1):4-7. doi: 10.1097/01.mat.0000247958.84788.3a. ASAIO J. 2007. PMID: 17237642

7

FDA's perspectives on cardiovascular devices.

Chen EA, Patel-Raman SM, O'Callaghan K, Hillebrenner MG. Chen EA, et al. J Cardiovasc Transl Res. 2009 Jun;2(2):143-6. doi: 10.1007/s12265-009-9096-7. Epub 2009 Mar 10. J Cardiovasc Transl Res. 2009. PMID: 20559979 Review.

8

Pediatric circulatory support: an FDA perspective.

Rinaldi JE, Chen EA, Berman MR. Rinaldi JE, et al. Among authors: chen ea. ASAIO J. 2005 Sep-Oct;51(5):533-5. doi: 10.1097/01.mat.0000181508.26853.dc. ASAIO J. 2005. PMID: 16322713

9

Food and Drug Administration's perspectives on pediatric cardiac assist devices.

Chen EA, Patel-Raman SM, Berman MR, Zuckerman BD. Chen EA, et al. ASAIO J. 2008 Mar-Apr;54(2):147-9. doi: 10.1097/MAT.0b013e318164a667. ASAIO J. 2008. PMID: 18356646

10

Orphanage at the FDA.

Chen E. Chen E. J Cardiovasc Transl Res. 2012 Oct;5(5):735-6. doi: 10.1007/s12265-010-9242-2. Epub 2010 Nov 16. J Cardiovasc Transl Res. 2012. PMID: 21080134 No abstract available.

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