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Results for 'Investigational device exemption'
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A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemptions Study of Lumbar Total Disc Replacement With the CHARITÉ™ Artificial Disc Versus Lumbar Fusion Publication Year: 2005
DOI: https://doi.org/10.1097/01.brs.0000170587.32676.0e
Abstract:
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Authors:
Scott L. Blumenthal
Paul C. McAfee
Richard D. Guyer
Stephen H. Hochschuler
Fred H. Geisler
Richard T. Holt
Rolando García
John J. Regan
Donna D. Ohnmeiss
Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc®-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease Publication Year: 2007
DOI: https://doi.org/10.1097/brs.0b013e318054e377
Abstract:
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Authors:
Jack E. Zigler
Rick B. Delamarter
Jeffrey M. Spivak
Raymond Linovitz
Guy O. Danielson
Thomas Haider
Frank P. Cammisa
Jim Zuchermann
Richard Balderston
Scott H. Kitchel
Kevin T. Foley
Robert G. Watkins
David S. Bradford
James J. Yue
Hansen A. Yuan
Harry N. Herkowitz
Doug Geiger
John A. Bendo
Timothy Peppers
Barton L. Sachs
Federico P. Girardi
Michael A. Kropf
Jeff Goldstein
Clinical and Hemodynamic Outcomes up to 7 Years After Transcatheter Pulmonary Valve Replacement in the US Melody Valve Investigational Device Exemption Trial Publication Year: 2015
DOI: https://doi.org/10.1161/circulationaha.114.013588
Abstract:
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Authors:
John P. Cheatham
William E. Hellenbrand
Evan M. Zahn
Thomas K. Jones
Darren P. Berman
Julie A. Vincent
Doff B. McElhinney
THA With Delta Ceramic on Ceramic: Results of a Multicenter Investigational Device Exemption Trial Publication Year: 2009
DOI: https://doi.org/10.1007/s11999-009-1091-4
Abstract:
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Authors:
William G. Hamilton
James P. McAuley
Douglas A. Dennis
Jeffrey A. Murphy
Thomas J. Blumenfeld
Joel Politi
A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of Lumbar Total Disc Replacement With the CHARITÉ ™ Artificial Disc Versus Lumbar Fusion Publication Year: 2005
DOI: https://doi.org/10.1097/01.brs.0000170561.25636.1c
Abstract:
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Authors:
Paul C. McAfee
Bryan W. Cunningham
Gwen Holsapple
Karen A. Adams
Scott L. Blumenthal
Richard D. Guyer
Anton Dmietriev
James H. Maxwell
John J. Regan
Jorge Isaza
Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up Publication Year: 2011
DOI: https://doi.org/10.3171/2011.5.spine10769
Abstract:
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Authors:
Domagoj Coric
Pierce D. Nunley
Richard D. Guyer
David B. Musante
Cameron Carmody
Charles Gordon
Carl Lauryssen
Donna D. Ohnmeiss
Margaret O. Boltes
Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease Publication Year: 2008
DOI: https://doi.org/10.1016/j.spinee.2008.05.006
Abstract:
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Authors:
Daniel B. Murrey
Michael Janssen
Rick B. Delamarter
Jeffrey A. Goldstein
Jack E. Zigler
Bobby Tay
Bruce V. Darden
Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials Publication Year: 2011
DOI: https://doi.org/10.3171/2011.6.spine10623
Abstract:
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Authors:
Cheerag D. Upadhyaya
Jau‐Ching Wu
Gregory R. Trost
Regis W. Haid
Vincent C. Traynelis
Bobby Tay
Domagoj Coric
Praveen V. Mummaneni
Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITÉ artificial disc versus lumbar fusion: Five-year follow-up Publication Year: 2008
DOI: https://doi.org/10.1016/j.spinee.2008.08.007
Abstract:
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Authors:
Richard D. Guyer
Paul C. McAfee
Robert Banco
Fabian D. Bitan
Andrew Cappuccino
Fred H. Geisler
Stephen H. Hochschuler
Richard T. Holt
Louis G. Jenis
Mohamed E. Majd
John J. Regan
Scott Tromanhauser
Douglas Wong
Scott L. Blumenthal
Reduced anticoagulation after mechanical aortic valve replacement: Interim results from the Prospective Randomized On-X Valve Anticoagulation Clinical Trial randomized Food and Drug Administration investigational device exemption trial Publication Year: 2014
DOI: https://doi.org/10.1016/j.jtcvs.2014.01.004
Abstract:
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Authors:
John D. Puskas
Marc W. Gerdisch
Dennis Nichols
Reed D. Quinn
Charles C. Anderson
Birger Rhenman
Lilibeth Fermin
Michael McGrath
Bobby Kong
Chad Hughes
Gulshan K. Sethi
Michael A. Wait
Tomas D. Martin
Allen Graeve
Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc Publication Year: 2004
DOI: https://doi.org/10.3171/spi.2004.1.2.0143
Abstract:
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Authors:
Fred H. Geisler
Scott L. Blumenthal
Richard D. Guyer
Paul C. McAfee
John J. Regan
J. Patrick Johnson
Bradford B. Mullin
Berlin Heart EXCOR Pediatric ventricular assist device Investigational Device Exemption study: Study design and rationale Publication Year: 2011
DOI: https://doi.org/10.1016/j.ahj.2011.05.026
Abstract:
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Authors:
Christopher S. Almond
Holger Buchholz
Patricia Massicotte
Rebecca Ichord
David N. Rosenthal
Karen Uzark
Robert D.B. Jaquiss
Robert Kroslowitz
M B Kepler
Aaron Lobbestael
David Bellinger
Elizabeth D. Blume
Charles D. Fraser
Robert H. Bartlett
Ravi R. Thiagarajan
Kathy J. Jenkins
Neurological Complications and Outcomes in the Berlin Heart EXCOR <sup>®</sup> Pediatric Investigational Device Exemption Trial Publication Year: 2015
DOI: https://doi.org/10.1161/jaha.114.001429
Abstract:
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Authors:
Lori C. Jordan
Rebecca Ichord
Olaf Reinhartz
Tilman Humpl
Sumit Pruthi
Christine Tjossem
David N. Rosenthal
Prospective study of cervical arthroplasty in 98 patients involved in 1 of 3 separate investigational device exemption studies from a single investigational site with a minimum 2-year follow-up Publication Year: 2010
DOI: https://doi.org/10.3171/2010.5.spine09852
Abstract:
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Authors:
Domagoj Coric
Joseph Cassis
John D. Carew
Margaret O. Boltes
Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study Publication Year: 2015
DOI: https://doi.org/10.3171/2015.1.spine14589
Abstract:
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Authors:
Matthew F. Gornet
J. Kenneth Burkus
Mark E. Shaffrey
Perry Argires
Hui Nian
Frank E. Harrell
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