PLC Medical Systems has received final approval from the U.S. Food and Drug Administration (FDA) to begin its U.S. trial on the efficacy of the company's RenalGuard to prevent contrast-induced nephropathy (CIN).
CIN can occur in older patients, diabetics, and patients with pre-existing renal impairment who are at risk during interventional procedures that use radiographic contrast media, PLC said.
RenalGuard is an automated, real-time fluid replacement device intended for patients who receive contrast media for interventional cardiology and radiology procedures. The system is based on high urine output during imaging procedures, allowing patients to rapidly eliminate toxins in contrast media and reduce potentially harmful effects.
The research builds upon two clinical trials by independent clinical investigators in Europe, which showed lower CIN incident rates in at-risk patients who used RenalGuard compared to standard of care, according to the company.
