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Food and Drug Administration

Circulatory System Devices Panel

December 8 , 2006

Open Public Hearing Speakers

2006-4253oph2_01 – – FDA Panel on DES – Dante Pazzanese, Alexandre Abizaid, Columbia University (pdf)

2006-4253oph2_02 – – A Prospective “All Comers” Single Arm Study in Complex Patients: The MATRIX Trial - IDE: G030229/S003CypherTM Sirolimus-Eluting Coronary Stent, Roxana Mehran, The Columbia University Medical Center (pdf)

2006-4253oph2_03 – – Drug-Eluting vs. Bare Metal Stents: Results from a Practice-Based Registry, David Kong (pdf)

2006-4253oph2_04 – – Longitudinal Outcomes Following Drug Eluting Stent Implantation, David Magid, Kaiser Permanente of Colorado, Kaiser Permanente of Northern California (pdf)

2006-4253oph2_05 – – Comparisons of Drug Eluting to Bare Metal Stents: Findings from the NHLBI-Dynamic and the DEScover Registries, David Williams, Rhode Island Hospital , Brown University (pdf)

2006-4253oph2_06 – – Prairie “Real World” Drug Eluting Stent Database, Gregory Mishkel, Prairie Cardiovascular, Springfield , Illinois (pdf)

2006-4253oph2_07 – Mark A. Turco – Washington Adventist Hospital (pdf)

2006-4253oph2_08 – – DES THROMBOSIS RESULTS FROM CONTEMPORARY REGISTRIES, Ron Waksman, Washington Hospital Center (pdf)

2006-4253oph2_09 – Drug Eluting Stents: Balancing Risks and Benefits, Sanjay Kaul, Cedars-Sinai Medical Center (pdf)

2006-4253oph2_10 – A Clinician's Perspective on Drug-Eluting Stents:Balancing Safety and Efficacy, Jeffery Moses, Columbia University Medical Center (pdf)

2006-4253oph2_11 – Relative Merits and Clinical Selection of CABG, Bare Metal Stents, and Drug Eluting Stents in Practice and in Evolution, Peter Smith, Duke University (pdf)

2006-4253oph2_12 – History of Evidence Based Coronary Revascularization –Can we identify our mistakes and not repeat them?, Robert Guyton, Emory University School of Medicine (pdf)

2006-4253oph2_13 – Summary Recommendations to FDA, Bruce Ferguson, Society of Thoracic Surgeons' Perspective, Brody School of Medicine at ECU (pdf)

2006-4253oph2_14 – Impact of DES in STEMI The Minneapolis Heart Institute Level 1 MI Program, Timothy Henry, Minneapolis Heart Institute Foundation (pdf)

2006-4253oph2_15 – – DES in Thrombosed Coronary Lesions, Jim Gustafson, Possis Medical Inc. (pdf)

2006-4253oph2_16 – – What is the Right Dose, Timing and Duration of Clopidogrel Therapy when Used with Drug Eluting Stents?, Robert Hillman, Accumetrics Inc. (pdf)

2006-4253oph2_17 – – Medtronic Vascular - Endeavor Safety Analysis, Rick Kuntz, Medtronic, Inc. (pdf)

2006-4253oph2_18 – – Abbott Vascular Drug Eluting Stent Program, Krishna Sudhir, Abbott Vascular (pdf)

2006-4253oph2_19 – – Planned Combined Safety Analysis for Stents Utilizing Biolimus A9® and Biodegradable Polymer, Laura Mauri, Harvard Clinical Research Institute (pdf)

2006-4253oph2_20 – – ACC Testimony, James T. Dove, American College of Cardiology (pdf)

2006-4253oph2_21 – Gregory J. Dehmer, SCAI (pdf)

2006-4253oph2_22 – – Protecting Patients Through Informed Consent and Appropriate Therapy, Frederick Grover, The Society of Thoracic Surgeons (pdf)

Unscheduled Speakers

2006-4253oph2-23- Rick Dulin (pdf)

2006-4253oph2-24 When Changing One Word Can Save a Life: Bare Instead of Eluting, Ryszard Rokicki, ELECTROBRIGHT (pdf)

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