SOURCE: RenalGuard Solutions, Inc.

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September 22, 2015 10:07 ET

Results From Investigator-Sponsored Study of RenalGuard System™ During TAVR Demonstrate Significant Reduction in AKI

MILFORD, MA--(Marketwired - September 22, 2015) - RenalGuard Solutions™, Inc., an innovative renal protection company, today announced that an investigator-sponsored study (PROTECT-TAVI) 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. The study titled "Acute Kidney Injury With the RenalGuard System in Patients Undergoing Transcatheter Aortic Valve Replacement" was published on-line in JACC: Cardiovascular Interventions by Dr. Marco Barbanti, Ferrarotto Hospital, University of Catania, Catania, Italy.

The 112 patient PROTECT-TAVI study reported a reduction in the rate of post-procedural AKI from 25.0% to 5.4% through the use of RenalGuard Therapy®. RenalGuard Therapy, the induction of high urine rates using RenalGuard's automated matched fluid replacement capabilities, has previously been shown to reduce the incidence of contrast-induced acute kidney injury (CI-AKI) following cardiac catheterizations in patients suffering from chronic kidney disease. This study enrolled all patients undergoing TAVR who were capable of receiving RenalGuard Therapy, regardless of underlying kidney function. In patients who did not have pre-existing kidney disease (eGFR >60), data reported in the paper indicated the use of RenalGuard reduced the incidence of post-procedural AKI from 18% to 0%.

"TAVR can be a life changing procedure for many patients with severe aortic stenosis. Several reports have demonstrated that developing AKI following TAVR significantly worsens long-term outcomes compared to those who do not suffer kidney damage, including increased mortality and higher health care costs," said Dr. Richard Solomon, Director of Nephrology at University of Vermont Medical Center and one of the Primary Investigators for the US pivotal trial of RenalGuard. "These results show that the use of RenalGuard can protect patients from the multi-factorial causes of AKI following TAVR, which should improve their long-term outcomes."

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. The PROTECT-TAVI study follows a number of other studies that 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, 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.

RenalGuard is currently available commercially in Europe. CIN-RG, the U.S. Pivotal Trial which evaluates the efficacy of RenalGuard Therapy and RenalGuard System compared to the current standard of care, is currently enrolling 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. The contrast dyes used in many cardiovascular diagnostic and interventional imaging procedures to facilitate the capture and display of x-ray images are known to be toxic to kidney cells. Approximately 10% to 20% of patients that undergo procedures using contrast are at-risk of developing Contrast-Induced Acute Kidney Injury (CI-AKI), which has been shown to lead to a higher need for dialysis and increased mortality. 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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