PLC Systems Receives FDA Approval To Commence Pivotal Study Of RenalGuard(TM) In The U.S.

PLC Systems Inc. (Amex: PLC) announced that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin enrollment in a U.S. pivotal trial to study the effectiveness of the Company's RenalGuard Therapy(TM) and RenalGuard System(TM) in the prevention of Contrast-Induced Nephropathy (CIN).Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "We are very pleased with the FDA's conditional approval to the Investigational Device Exemption (IDE) supplement we filed last month. This will enable us to commence our pivotal study on schedule this spring. We are focused now on incorporating FDA's input into our final study protocol, and rapidly moving through the next phase of our clinical trial plan, which includes securing approvals to begin our study from hospital Institutional Review Boards at the sites that have elected to participate. FDA approval of the IDE is another major milestone on our path forward to commercializing the RenalGuard therapy and system, and we are very excited about beginning the pivotal trial."

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