PLC Systems nabs FDA approval for U.S. RenalGuard study

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PLC Systems has received conditional approval from the FDA to begin enrollment in a U.S. pivotal trial to study the effectiveness of its RenalGuard Therapy and RenalGuard System in the prevention of contrast-induced nephropathy (CIN).

CIN is a major and growing 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, said the Franklin, Mass.-based company.

Enrollment in the adaptive, randomized controlled trial at up to 30 sites in the United States is expected to last through 2009, and will include a minimum of 246 patients.

The study will be 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.