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news.PLC Systems has submitted an investigational device exemption or IDE supplement with the FDA for its RenalGuard Therapy and RenalGuard System.
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This supplement seeks approval to move to a pivotal trial to study the effectiveness in the prevention of contrast-induced nephropathy. PLC expects to commence the pivotal trial after receipt of FDA approval. 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. A total of 23 patients were enrolled in the study.
This study is designed as an adaptive, randomized control trial, with potentially up to 30 sites in the US. 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.