PLC Systems (PLC) Receives FDA Conditional Approval to Commence Pivotal Study Of RenalGuard
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PLC Systems Inc. (Amex: PLC) received conditional approval from the FDA to begin enrollment in a U.S. pivotal trial to study the effectiveness of the Company's RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy.
Contrast-Induced Nephropathy, or 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. [LJ]
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