PLC Systems of Franklin, MA, has received approval from the Centro Cardiologico Monzino (CCM-University of Milan) of Milan, Italy, for a randomized clinical trial to evaluate the use of its RenalGuard product.
RenalGuard is an automated, real-time, matched fluid replacement device for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. It is designed to prevent contrast-induced nephropathy (CIN) in high-risk patients undergoing catheterization procedures.
The objective of the clinical trial will be to assess the potential benefits of induced diuresis with matched hydration therapy, compared to standard overnight hydration, in the prevention of CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function.
Researchers in the study will use RenalGuard to provide CIN-prevention therapy of induced diuresis and matched hydration therapy.
Related Reading
PLC Systems inks Italian distribution pact, March 28, 2008
PLC to enroll patients in CIN study, March 21, 2008
PLC Systems unveils CIN prevention technology, September 15, 2006
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