PLC Systems Files IDE Supplement to Begin Pivotal Study of RenalGuard(TM) and Provides Update on Planned Developmen...( FRANKLIN Mass. Feb. 15 /- PLC Sys...),Health

FRANKLIN, Mass., Feb. 15 /PRNewswire-FirstCall/ -- PLC Systems Inc. (Amex: PLC) announced today that it has submitted an Investigational Device Exemption (IDE) supplement with the U.S. Food & Drug Administration (FDA) for its RenalGuard Therapy(TM) and RenalGuard System(TM). 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. This study is designed as an adaptive, randomized control trial, with potentially up to 30 sites in the U.S. Enrollment in the trial is expected to last through 2009, and to include at least 250 patients. PLC is continuing discussions with FDA on metrics and endpoints to be used in the study, in addition to sample size and other aspects of the study design, which is currently expected to cost approximately $3 million.

This trial design builds upon the successful completion of the company's pilot trial in December, a study that was designed to preliminarily evaluate safety associated with Renal Guard Therapy and RenalGuard System. A total of 23 patients were enrolled in the study.

Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "We are very pleased with the continued progress on our RenalGuard studies. Submitting the IDE for t
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