PLC Medical Systems, Inc., of Franklin, Mass., has received full approval for a U.S. pivotal trial to study the effectiveness of its RenalGuard System and associated therapy in the prevention of contrast-induced nephropathy (CIN).

RenalGuard is a fully automated fluid-replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.

The third most common cause of in-hospital acute renal failure, CIN is associated with increases in long-term mortality rates, major in-hospital adverse cardiac events, and the risk of having to undergo renal dialysis therapy.

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