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Food and Drug Administration

Circulatory System Devices Panel

December 7 , 2006

Open Public Hearing

The Vascular Pathology of Drug Eluting Stents: Delayed Healing and Late Thrombotic Risk, Herman Gold, CVPath and Massachusetts General Hospital (pdf)

Late Stent Thrombosis After DES: Role of Platelet Function Testing, Alan Michelson, Center for Platelet Function, University of Massachusetts Medical School (pdf)

Impact of Stent Thrombosis on Outcomes of Death and MI after Drug-Eluting Stenting - Importance of Standard Definitions and Analytical Methods, Don Cutlip, Harvard Clinical Research Institute Harvard Medical School (pdf)

Perspectives on Drug-eluting Stent Safety and Efficacy with Regulatory Recommendations, Gregg W. Stone, Columbia University Medical Center Cardiovascular Research Foundation (pdf)

Four-Year Follow-up of Sirolimus-eluting Stents in Comparison with Bare Metal Stents: A Pooled Safety Analysis of the RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS Trials in 1,748 Patients, Patrick Serruys, Erasmus Medical Center (pdf)

Incidence and Predictions of Drug Eluting Stent Thrombosis during and Following Discontinuation of Thienopyrdine Treatment, Antonio Colombo, Centro Cuore Columbus S. Raffaele Hospital (pdf)

Long-term outcome of DES vs BMS implanted in Sweden 2003 – 2004, Lars Wallentin, Uppsala Clinical Research Centre, UCR, Uppsala University (pdf)

Late Coronary Stent Thrombosis of DES in Routine Clinical Practice - Data from a Large Two-Institutional Cohort Study, Patrick Serruys, Erasmus Medical Center (pdf)

Patrick Serruys – Thoraxcenter real world experience – Erasmus Medical Center (pdf)

Preliminary One-Year Outocome After Sirolimus-eluting Stent Implantation The j-Cypher Registry Update, Takeshi Kimura Kyoto University Hospital (pdf)

Meta-Analyses of Randomized Trials of Sirolimus-Eluting Stents vs. Paclitaxel-Eluting Stents or Bare Metal Stents: An Independent, Individual Patient Data Based Study, Adnan Kastrati, Deutsches Herzezentrum (pdf)

ARTS II Data entitled: “ Adjudication of events for FDA Panel, Gerrit-Anne van Es, Cardialysis, the Netherlands(pdf)

Drug-Eluting Stent Safety Profile Stent Thrombosis, Campbell Rogers, Cordis (pdf)

“Real-World” Use of the CYPHER Sirolimus-Eluting Stent, Data from Randomized Controlled Trials and Registries, Sidney A. Cohen, Cordis (pdf)

On-label Use of the TAXUS Drug-eluting Stent System, Donald S. Baim, Boston Scientific Corporation (pdf)

Real-world use of the TAXUS Drug-eluting Stent System, Donald S. Baim, Boston Scientific Corporation (pdf)

FDA Summary, Takahiro Uchinda, Andrew Farb, Andrea Holton, Hesha Duggirala (pdf)

Stent Thrombosis: The Implications of Broader DES Use, Robert P. Fiorentino, FDA (pdf)

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