CIRCULATORY SYSTEM DEVICES PANEL

February 5, 2001

Percusurge Guardwire PlusŪ Temporary Occlusion & Aspiration System

Sponsor Presentation
- Percusurge-Medtronic K003992

Introduction to the use of the PercuSurge GuardWire System in the SAFER Randomized Trial, Dennis W Wahr, MD, FACC, Michigan Heart & Vascular Institute   pdf

Evaluation of the Clinical Safety and Efficacy of the PercuSurge GuardWire in Saphenous Vein Graft Intervention, Donald S Baim, MD, FACC, Harvard Medical School , Brigham and Women's Hospital   pdf

Statistical Considerations, Richard Kuntz, Harvard Medical School, Brigham and Women's Hospital   pdf

Using the PercuSurge GuardWire System, Dennis W Wahr MD FACC   pdf

FDA Presentation   ppt   html

Clinical Study Design Issues for Distal Protection
Devices used in SVG Disease

FDA Presentation , Bram Zuckerman, M.D.   ppt   html