Feb. 15 , 2008 - PLC Systems Inc. (Amex: PLC) announced that it has submitted an Investigational Device Exemption (IDE) supplement with the U.S. Food & Drug Administration (FDA) for its RenalGuard Therapy™ and RenalGuard System™. This supplement seeks approval to move to a pivotal trial to study the effectiveness of the Company's RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy. According to the current timetable, PLC expects to commence the pivotal trial after receipt of FDA approval. 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... PLC Systems' Press Release -
Wednesday, March 5, 2008
PLC Systems' RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy
Feb. 15 , 2008 - PLC Systems Inc. (Amex: PLC) announced that it has submitted an Investigational Device Exemption (IDE) supplement with the U.S. Food & Drug Administration (FDA) for its RenalGuard Therapy™ and RenalGuard System™. This supplement seeks approval to move to a pivotal trial to study the effectiveness of the Company's RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy. According to the current timetable, PLC expects to commence the pivotal trial after receipt of FDA approval. 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... PLC Systems' Press Release -
