PLC Preps For RenalGuard Trial
Franklin medical device company PLC Systems Inc. is preparing to start a trial of its RenalGuard product as it seeks approval for sales and marketing from the U.S. Food and Drug Administration.
RenalGuard, which is already approved for use in the European Union, is intended to prevent patients from developing a condition known as contrast-induced nephropathy. The condition can cause renal failure in patients who already have kidney problems when they are given iodinated radiocontrast agents as part of imaging procedures.
RenalGuard is designed to help keep patients appropriately hydrated to help prevent the condition.
PLC has enlisted Roxana Mehran, a professor of medicine at Mount Sinai School of Medicine as a principal investigator for the trial.
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