PLC Medical Enrolls RenalGuard Trial

PLC Medical Systems has enrolled the first patients in its FDA-approved clinical trial designed to evaluate the safety of its RenalGuard System. RenalGuard is an investigational therapy targeting patients with diminished renal function who may be at risk for Contrast-Induced Nephropathy (free registration required).

RenalGuard is a real-time fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. Based on existing data, PLC believes initiating and maintaining high urine output will allow the body to rapidly eliminate contrast media, reducing its toxic effects.

Approximately seven million patients worldwide undergo interventional therapeutic and diagnostic procedures each year. Contrast-Induced Nephropathy (CIN) is a growing concern due to the increasing number of older patients, diabetics and patients with pre-existing renal failure. They are at increased risk for CIN when they require interventional procedures that use radiographic contrast media. CIN is the third-most common cause of in-hospital acute renal failure.

PLC has heretofore focused on a surgical procedure known as transmyocardial revascularization, a medical treatment option for patients who suffer from severe coronary artery disease.

19 March 2007 | Blog | Douglas Cress | Comments