Publications by authors named "Bram D Zuckerman"

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Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review.
David R Holmes, Andrew A Farb, Robert Chip Hance, Martin B Leon, Pamela Goldberg, Bram D Zuckerman

J Am Coll Cardiol· December 2020

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Clinical event adjudication in cardiovascular device trials: An Food and Drug Administration perspective.
Andrew Farb, Bram D Zuckerman

Am Heart J· September 2017

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Patent Foramen Ovale after Cryptogenic Stroke - Assessing the Evidence for Closure.
Andrew Farb, Nicole G Ibrahim, Bram D Zuckerman

N Engl J Med· September 2017

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Mitral Valve Academic Research Consortium consensus report: the U.S. Food and Drug Administration perspective.
John C Laschinger, Nicole G Ibrahim, Bram D Zuckerman

Eur Heart J· August 2015

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Mitral Valve Academic Research Consortium Consensus Report: The U.S. Food and Drug Administration Perspective.
John C Laschinger, Nicole G Ibrahim, Bram D Zuckerman

J Am Coll Cardiol· July 2015

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Transcatheter valve therapy registry is a model for medical device innovation and surveillance.
John D Carroll, Jeff Shuren, Tamara Syrek Jensen, John Hernandez, David Holmes, Bram D Zuckerman

Health Aff (Millwood)· February 2015

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Food and Drug Administration commentary on "a new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves".
Fernando Aguel, Steven B Kurtzman, Sonna Patel-Raman, Matthew Hillebrenner, Bram D Zuckerman

J Thorac Cardiovasc Surg· October 2013

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Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.
Daniel B Kramer, Elias Mallis, Bram D Zuckerman, Barbara A Zimmerman, William H Maisel

Am J Ther· March 2010

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Food and Drug Administration's perspectives on pediatric cardiac assist devices.
Eric A Chen, Sonna M Patel-Raman, Michael R Berman, Bram D Zuckerman

ASAIO J· May 2008

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High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.
Christopher S D Almond, Eric A Chen, Michael R Berman, Joanne R Less, J Timothy Baldwin, Bram D Zuckerman

ASAIO J· February 2007

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Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports.
William H Maisel, Megan Moynahan, Bram D Zuckerman, Thomas P Gross, Oscar H Tovar

JAMA· April 2006

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Key issues in end point selection for heart failure trials: composite end points.
James D Neaton, Gerry Gray, Bram D Zuckerman, Marvin A Konstam

J Card Fail· October 2005

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Challenges in regulating breakthrough medical devices.
Neal I Muni, Thomas P Gross, Ashley B Boam, Stanley Wang, Bram D Zuckerman

Food Drug Law J· August 2005

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Cardiovascular device development: an FDA perspective.
Bram D Zuckerman, Neal I Muni

Am J Ther· July 2005

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Coronary drug-eluting stent development: issues in trial design.
Neal I Muni, Robert M Califf, Jonette R Foy, Ashley B Boam, Bram D Zuckerman

Am Heart J· March 2005

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Preclinical evaluation of drug-eluting stents for peripheral applications: recommendations from an expert consensus group.
Robert S Schwartz, Elazer R Edelman, Andrew Carter, Nicolas A Chronos, Campbell Rogers, Bram D Zuckerman

Circulation· October 2004

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Mismatching of annular sizers and cardiac prosthetic valve sewing cuff sizes.
Bram D Zuckerman

Ann Thorac Surg· July 2003

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Prosthetic cardiac valve replacement.
Bram D Zuckerman, Wolf Sapirstein

J Thorac Cardiovasc Surg· June 2003

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Drug-eluting stents in preclinical studies: recommended evaluation from a consensus group.
Robert S Schwartz, Elazer R Edelman, Andrew Carter, Nicolas Chronos, Campbell Rogers, Bram D Zuckerman

Circulation· October 2002

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