PLC Systems Inc. is a medical device company focused on innovative technologies for the cardiac and vascular markets. The company’s newest product, RenalGuard, has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain imaging procedures.
The company today announced that it is preparing to start the pivotal trial in the US for RenalGuard as it seeks approval for sales and marketing in the United States from the Food and Drug Administration. RenalGuard has already obtained CE Mark approval in the European Union.
The RenalGuard system consists of a patented closed loop, software-controlled console and proprietary single-use sets that physicians and nurses use for automated matched fluid replacement to minimize over- or under-hydration of patients during medical procedures where creating and maintaining high urine outputs is beneficial.
As part of PLC Systems’ effort, the company has added Roxana Mehran, MD, professor of medicine at Mount Sinai School of Medicine, as principal investigator for the trial. She is well known worldwide for her work and leadership in the field of CIN prevention. Dr. Mehran is internationally recognized for her work as a clinical trial specialist and for her expertise in working with regulatory agencies to conduct clinical trials.
For additional information on PLC Systems, please visit the company’s website at www.plcmed.com