PLC's US Pivotal Study of RenalGuard Approved

October 14, 2011—PLC Medical Systems, Inc. (Milford, MA) announced that it has received final approval from the US Food and Drug Administration to commence its United States pivotal trial to study the efficacy of the company's RenalGuard therapy and RenalGuard system for the prevention of contrast-induced nephropathy.

PLC's pivotal study is designed as an adaptive, randomized controlled trial that will take place at up to 30 sites in the United States. Enrollment in the trial will include at least 326 patients and potentially up to 652 patients, depending on the outcome of a sample size re-estimation after 163 patients are enrolled. The company noted that the sample size re-estimation, which is often used in adaptive trials, enables investigators to ensure that the trial is sufficiently powered so that the final results are statistically meaningful. The study's Principal Investigators are Charles Davidson, MD; Richard J. Solomon, MD; and Roxana Mehran, MD.

According to the company, the study in the United States builds on two clinical trials by independent clinical investigators in Europe, both of which showed significant reductions in incident rates of contrast-induced nephropathy in at-risk patients with the use of RenalGuard compared to the current standard of care.

PLC explained that RenalGuard therapy is based on data that show that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate the toxins that are in contrast media, reducing their harmful effects. RenalGuard is a fully automated, real-time-matched fluid replacement device that is intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. RenalGuard has not been approved for use in the United States, the company advised.