SOURCE: RenalGuard Solutions, Inc.

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November 02, 2016 09:50 ET

Population-Controlled Study Shows Increased Progression of Chronic Kidney Disease and Poorer Outcomes in PCI Patients With CI-AKI

MILFORD, MA--(Marketwired - November 02, 2016) - RenalGuard Solutions™, Inc., an innovative renal protection company, today announced the publication of an article in the Journal of the American Heart Association detailing the results of a landmark study examining the relationship between chronic kidney disease and cardiovascular outcomes in cardiac catheterization patients. While a number of studies have indicated that Contrast-Induced Acute Kidney Injury (CI-AKI) in these patients are associated with worse outcomes, it has been hard to determine the impact the procedure itself has had on the progression of kidney disease.

The paper, "Chronic Kidney Disease Progression and Cardiovascular Outcomes Following Cardiac Catheterization - A Population-Controlled Study," presents a retrospective analysis of 24,405 patients identified through the Veterans Affairs Clinical Assessment, Reporting, and Tracking Registry, who underwent Percutaneous Coronary Intervention (PCI) between 2005 and 2010, and compared their results with 24,405 control patients who did not undergo PCI.

The study showed that developing CI-AKI after PCI increases the risk for the progression of Chronic Kidney Disease (CKD), dialysis initiation, acute myocardial infarction and death, compared to patients without this condition. It also showed an increased risk for these conditions in PCI patients, even in the absence of CI-AKI, after cardiac catheterization.

The authors hypothesized that the negative impact of PCI on CKD progression, dialysis and mortality may be due to "sub-clinical" contrast-associated injury. They conclude, "We recommend further investigations to identify both system improvements and novel therapeutic agents to prevent CCA-AKI, and to reduce CKD progression and associated morbidity and mortality following PCI."

"This study provides additional insight into the risk of further kidney damage in high-risk PCI patients," said Andrew Halpert, President, RenalGuard Solutions, Inc. "We have decades of research demonstrating that patients who meet the classical definition of CI-AKI, a sharp rise in serum creatinine levels, have significantly worse long-term outcomes than patients who did not see a spike in their serum creatinine. This is the first large study to evaluate the impact of both CI-AKI and the cardiovascular intervention on long-term outcomes. The finding that patients who received a cardiovascular intervention had worse long-term outcomes than those who did not, suggests that even patients who do not meet the classical definition of AKI suffer some injury to their kidney, and that this injury worsens their long-term outlook. This helps explain the finding from the AKIGUARD study that reported that treatment with RenalGuard reduced long-term adverse events, hospital days, and worsening renal function by an even larger margin than it reduced the incidence of CI-AKI."

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 studies have demonstrated RenalGuard's ability to protect patients from AKI following catheterization procedures when compared to the standard of care, including: MYTHOS, which found RenalGuard to be superior to overnight hydration; REMEDIAL II, which found RenalGuard to be superior to sodium bicarbonate hydration; Protect-TAVI, which reported a significant reduction in post-procedural acute kidney injury (AKI) following transcatheter aortic valve replacement (TAVR) when using RenalGuard during the procedure, compared to standard therapy; and AKIGUARD, which showed significant improvement in long-term outcomes when using RenalGuard vs. standard therapy.

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.

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