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MILFORD, MA --(Marketwired - January 26, 2016) - RenalGuard Solutions™, Inc., an innovative renal protection company, today announced the STRENGTH trial, designed to evaluate the long-term clinical and economic impact of RenalGuard Therapy® in patients at high risk for Contrast-Induced Acute Kidney Injury (CK-AKI), will begin later this year. The co-primary investigators for this study are Dr. Philippe Garot, Head of Interventional Cardiology, the Insitut Cardiovasculaire Paris Sud, France, and Prof. Dr. med. Horst Sievert, Director and Founder, CardioVascular Center (CVC) Frankfurt, Germany. The study, which is expected to enroll up to 300 patients, will be independently conducted by CERC.
RenalGuard® measures a patient's urine output and automatically infuses hydration fluid based on that urine output. The system is designed to induce high urine rates, which have been shown to protect the kidney from a range of insults.
A number of clinical trial results have demonstrated RenalGuard's ability to protect patients from AKI following catheterization procedures when compared to the standard of care, including: Protect-TAVI, which reported a significant reduction in post-procedural acute kidney injury (AKI) following transcatheter aortic valve replacement (TAVR); MYTHOS, which found RenalGuard to be superior to overnight hydration; REMEDIAL II, which found RenalGuard to be superior to sodium bicarbonate hydration; and AKIGUARD, which reported that patients treated with RenalGuard had reduced major adverse events and hospital stays at one year when compared to standard therapy. The company recently announced the publication of the results of an additional study that confirmed the previous clinical trial results in 400 patients.
About RenalGuard Solutions, Inc.
RenalGuard Solutions, Inc. is a medical device company focused on innovative technologies for the cardiac and vascular markets. Our lead product, RenalGuard, is designed to protect patients from acute kidney injury (AKI), including contrast-induced AKI. Two investigator-sponsored studies in Europe have demonstrated RenalGuard's effectiveness at preventing CI-AKI in at-risk patients. RenalGuard is CE-marked and is being sold in Europe and certain countries around the world via a network of distributors. The CIN-RG RenalGuard pivotal study is underway in the U.S. to support a planned Premarket Approval filing with the U.S. Food and Drug Administration. For further information, please visit the website at www.RenalGuard.com.