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Food and Drug Administration

Circulatory System Devices Panel

October 11, 2007


Carotid Stent Issues PMA Meeting

FDA Presentation (pdf)

Open Public Hearing - Presentations

"FDA Panel Open Session: Clinical Trial Designs for CAS in Patients Not at High Risk for Adverse Events from Surgical Revascularization," Dr. Stan Fink, Abbot Vascular (pdf)

"TACIT: Transatlantic Asymptomatic Carotid Intervention Tria," Dr. John Runback (pdf)

Dr. Chris White; Representing SCAI & ACC (pdf)

"Carotid Interventions Evidenced-based Guidance For Clinical Therapy," Dr. Rodney White (pdf)

"SVS CAS Concepts," Dr. Robert Zwolak (pdf)

"Trial Designs of Carotid Artery Stenting in Conventional Risk Patients," Dr. Irene Katzan, on behalf of the American Academy of Neurology (pdf)

Open Public Hearing - Statements

AHA Comments: "Trial Design for Carotid Artery Stenting" (pdf)

AAN Comments: "Trial Designs for Carotid Artery Stenting" (pdf)

SCAI Comments: "Clinical Trial Design Issues For Carotid Artery Stents Intended To Reopen Stenotic Carotid Arteries In The Neck" (pdf)

SIR Foundation Comments: "TACIT: Transatlantic Asymptomatic Carotid Intervention Trial" (pdf)

SVS Comments: "Clinical Trial Designs for Carotid Artery Stenting in Patients not at High Risk" (pdf)

AHA Article: LoGerfo, Frank W. "Carotid Stents Unleashed, Unproven;" (pdf)Circulation 2007;116;1596-1601 (pdf)

AHA Article: Samuelson et al. "The Argument to Support Broader Application of Extracranial Carotid Artery Stent Technology;" Circulation 2007;116;1602-1610 (pdf)

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