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FDA approves PLC Systems to begin RenalGuard System US pivotal trial

The US Food and Drug Administration (FDA) has approved PLC Systems to start RenalGuard Therapy and RenalGuard System US pivotal trial to treat Contrast-Induced Nephropathy (CIN).

RenalGuard is a fully-automated, real-time matched fluid replacement device designed for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.

The company said initiating and maintaining high urine output during imaging procedures allows the body to eliminate toxins in contrast media, reducing their harmful effects.

The trial is an adaptive, randomized controlled at up to 30 sites in the US and is designed to evaluate the efficacy of the RenalGuard System.

The company said enrollment in the trial will include at least 326 patients and potentially up to 652 patients, depending upon the outcome of a sample size re-estimation after 163 patients.

PLC Systems president and CEO Mark Tauscher said using lessons learned from the clinical trials of RenalGuard in Europe as well as other clinical developments since 2008, they made slight modifications to their original trial protocol and they believe will make it more scientifically significant.

"We are now finalizing our submissions to the hospital Institutional Review Boards and will begin enrolling patients in the near future," Tauscher said.