PLC Systems Inc., a company focused on innovative medical device technologies, announced that it has received final approval from the US Food and Drug Administration (US FDA) to commence its US pivotal trial to study the efficacy of the company's RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy (CIN).
Mark R Tauscher, president and chief executive officer of PLC, said, “We've very pleased to be able to move forward with our US pivotal trial, starting with many of the hospitals that had participated in our earlier trial. Using lessons learned from the clinical trials of RenalGuard in Europe as well as other clinical developments since 2008, we made slight modifications to our original trial protocol that we 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. This is the first step on our path forward to seeking US FDA approval to market the RenalGuard therapy and system in the US.”
PLC's US pivotal study is under the supervision of Principal Investigators Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School, Richard J Solomon, MD, Professor of Medicine, University of Vermont College of Medicine and Roxana Mehran, MD, Professor of Medicine at Mount Sinai School of Medicine. It is designed as an adaptive, randomized controlled trial at up to 30 sites in the US 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. The sample size re-estimation, often used in adaptive trials, enables investigators to ensure that the trial is sufficiently powered so that the final results are statistically meaningful.
PLC's US study builds upon two clinical trials by independent clinical investigators in Europe, both of which showed significant reductions in incident rates of CIN in at-risk patients through the use of RenalGuard compared to the current standard of care.
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. More than 7 million such imaging procedures occur worldwide each year, and it is estimated that 15-20 per cent of those patients are 'at risk' of acquiring CIN. CIN is the third most common cause of in-hospital acute renal failure. It is associated with significant in-hospital mortality rates, and increases in long-term mortality rates, major in-hospital adverse cardiac events, and increased risk of renal dialysis therapy. All of these lead to prolonged hospital stays and increased medical costs. Estimated mortality rate for patients who acquire CIN may be as high as 35 per cent.
RenalGuard is based on data that shows that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. It is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.