114
Participants
Start Date
July 1, 2017
Primary Completion Date
January 31, 2018
Study Completion Date
March 30, 2018
DyeVert Plus Contrast Reduction System
The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient.
WakeMed Heart and Vascular, Raleigh
Atlanta VA Medical Center, Emory University School of Medicine, Atlanta
North Mississippi Medical Center, Tupelo
Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati
William Beaumont Hospital, Royal Oak
University of Chicago Medical Center, Chicago
Washington University School of Medicine, St Louis
Harbor UCLA Medical Center, Torrance
Lead Sponsor
Osprey Medical, Inc
INDUSTRY