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PLC Systems Inc.announced that it has received full approval from the U.S. Food and Drug Administration (FDA) for its U.S. pivotal trial to study the effectiveness of the Company's RenalGuard System and associated therapy in the prevention of Contrast-Induced Nephropathy (CIN).

The FDA also approved PLC's request to expand their investigation from the 246 patients conditionally approved earlier this year to 406 patients and eliminate the requirement for an interim study analysis to be performed. As a result of this and other changes, the study is no longer considered an adaptive study.

Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "We are very pleased with the FDA's full approval to the Investigational Device Exemption (IDE) supplement we filed in February to study RenalGuard in the U.S. While we have deferred the onset of the trial pending receipt of funding to complete it, the investigator-sponsored clinical trial at the Cardiologico Centrino Monzino (CCM) -University of Milan in Italy is continuing, as are our commercialization efforts in Europe, under the CE Mark we received in late 2007. Full FDA approval of the IDE supplement is another major milestone on our path forward to commercializing RenalGuard™ in the U.S., and with its receipt, we are well-positioned to begin the trial with our targeted study sites, once we have the needed funding."

Mr. Tauscher added, "We remain very confident that RenalGuard is a highly promising therapy addressing a large, unmet market need. We are optimistic that the results from the CCM study will provide critical validation for our technology, and support our efforts to raise funding for the U.S. pivotal study as well."

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. The Company's U.S. pivotal study, 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, is designed as a randomized controlled trial at up to 30 sites in the U.S. Enrollment in the trial will now include 406 patients.

Source: http://www.plcmed.com/press217851544.asp