PLC Systems of Franklin, MA, has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin enrollment in a trial to study its RenalGuard product for preventing contrast-induced nephropathy (CIN).
RenalGuard is an automated, real-time matched-fluid replacement device designed for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.
CIN can cause acute renal failure and lead to adverse cardiac events and the need for renal dialysis. According to PLC, studies indicate that approximately 15% to 20% of patients undergoing image-guided cardiology and radiology procedures are at risk of developing CIN.
Related Reading
PLC Systems unveils CIN prevention technology, September 15, 2006
Assessing patient risk will help prevent contrast-induced nephropathy, June 15, 2006
Firm raises eyebrows with push to enforce antikidney-failure patent, June 13, 2006
Part II: Palliative steps prevent contrast-induced nephropathy, September 20, 2005
Part I: Identifying patients at risk of contrast-induced nephropathy, September 13, 2005
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