Zuckerman BD - Search Results

1

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. Among authors: zuckerman bd. ASAIO J. 2007 Jan-Feb;53(1):4-7. doi: 10.1097/01.mat.0000247958.84788.3a. ASAIO J. 2007. PMID: 17237642

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. 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

FDA perspective on clinical trial design for cardiovascular devices.

Chen E, Sapirstein W, Ahn C, Swain J, Zuckerman B. Chen E, et al. Ann Thorac Surg. 2006 Sep;82(3):773-5. doi: 10.1016/j.athoracsur.2006.07.044. Ann Thorac Surg. 2006. PMID: 16928481 No abstract available.

4

US FDA perspective on regulatory issues affecting circulatory assist devices.

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

5

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

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

6

Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC).

Waksman R, Pahuja M, van Diepen S, Proudfoot AG, Morrow D, Spitzer E, Nichol G, Weisfeldt ML, Moscucci M, Lawler PR, Mebazaa A, Fan E, Dickert NW, Samsky M, Kormos R, Piña IL, Zuckerman B, Farb A, Sapirstein JS, Simonton C, West NEJ, Damluji AA, Gilchrist IC, Zeymer U, Thiele H, Cutlip DE, Krucoff M, Abraham WT. Waksman R, et al. Circulation. 2023 Oct 3;148(14):1113-1126. doi: 10.1161/CIRCULATIONAHA.123.064527. Epub 2023 Oct 2. Circulation. 2023. PMID: 37782695 Free PMC article. Review.

7

Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.

Kramer DB, Mallis E, Zuckerman BD, Zimmerman BA, Maisel WH. Kramer DB, et al. Among authors: zuckerman bd. Am J Ther. 2010 Jan-Feb;17(1):2-7. doi: 10.1097/MJT.0b013e3181ca8105. Am J Ther. 2010. PMID: 20038828

8

Improving Heart Failure Therapeutics Development in the United States: The Heart Failure Collaboratory.

O'Connor CM, Psotka MA, Fiuzat M, Lindenfeld J, Abraham WT, Bristow MR, Canos D, Harrington RA, Hillebrenner M, Jessup M, Malik FI, Solomon SD, Stockbridge N, Tcheng JE, Unger EF, Whellan DJ, Zuckerman B, Califf RM. O'Connor CM, et al. J Am Coll Cardiol. 2018 Jan 30;71(4):443-453. doi: 10.1016/j.jacc.2017.11.048. J Am Coll Cardiol. 2018. PMID: 29389362 Free article. Review.

9

Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review.

Holmes DR Jr, Farb AA, Chip Hance R, Leon MB, Goldberg P, Zuckerman BD, Kaplan AV, Rincon-Gonzalez L, Hunt J, Walkowiak J, Mack MJ. Holmes DR Jr, et al. Among authors: zuckerman bd. J Am Coll Cardiol. 2020 Dec 8;76(23):2786-2794. doi: 10.1016/j.jacc.2020.10.019. J Am Coll Cardiol. 2020. PMID: 33272373 Free article. Review.

10

Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports.

Maisel WH, Moynahan M, Zuckerman BD, Gross TP, Tovar OH, Tillman DB, Schultz DB. Maisel WH, et al. Among authors: zuckerman bd. JAMA. 2006 Apr 26;295(16):1901-6. doi: 10.1001/jama.295.16.1901. JAMA. 2006. PMID: 16639048

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