Pivotal Study Okayed for Nephropathy Prevention Device

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PLC Systems Inc., of Franklin, Mass., has received conditional approval to begin enrollment in a pivotal trial to study the effectiveness of its RenalGuard Therapy and RenalGuard System in the prevention of contrast-induced nephropathy (CIN).

 

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.

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