PLC Systems Receives Full FDA Approval for Pivotal Study of RenalGuard(TM) i... (owing problem due to the increasing numb...)

PLC Systems Receives Full FDA Approval for Pivotal Study of RenalGuard(TM) in The U.S.

Date:11/26/2008

owing problem due to the increasing number of older patients, diabetics and patients with pre-existing renal impairment - all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. The Company's U.S. pivotal study, under the supervision of principal investigators Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School and Richard J. Solomon, MD, Professor of Medicine, University of Vermont College of Medicine, is designed as a randomized controlled trial at up to 30 sites in the U.S. Enrollment in the trial will now include 406 patients.

Contrast-Induced Nephropathy

Approximately seven million patients worldwide undergo interventional cardiovascular therapeutic and diagnostic imaging procedures each year. CIN is the third most common cause of in-hospital acute renal failure. It is associated with significant in-hospital mortality rates, and increases in long-term mortality rates, major in-hospital adverse cardiac events, and the risk of having to undergo renal dialysis therapy. Any of these can result in prolonged hospital stays and increased medical costs. Studies indicate that approximately 15-20% of all patients undergoing image-guided cardiology and radiology procedures are at risk of developing CIN. The estimated mortality rate for patients that acquire CIN may be as high as 35%.

About RenalGuard

RenalGuard is based on existing pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. '/>"/>

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