Pivotal Study Okayed for Nephropathy Prevention Device
PLC Systems Inc., of
RenalGuard is an automated fluid-replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures, based on clinical data that suggest that a high urine output during imaging allows for rapid elimination of toxins in contrast media, reducing their harmful effects.
Older patients, diabetics, and patients with pre-existing renal impairment are at elevated risk for CIN when undergoing interventional procedures requiring radiographic contrast media. Enrollment in the pivotal study is expected to last through 2009.