MILFORD, MA--(Marketwired - October 31, 2016) - RenalGuard Solutions™, Inc., an innovative renal protection company, today announced that an investigator-sponsored prospective study reported on the results of the use of RenalGuard® to protect high-risk patients from acquiring Contrast-Induced Acute Kidney Injury (CI-AKI) when undergoing procedures requiring contrast. The study, "Prevention of post procedural acute kidney injury in the catheterization laboratory in a real-world population," will be published later this month by Shmuel Banai, M.D., Director of Interventional Cardiology, Tel Aviv Medical Center, Tel Aviv, Israel, in the International Journal of Cardiology.
The study is a single-center, retrospective analysis of prospectively collected data. A total of 150 consecutive patients undergoing coronary angiography, angioplasty or TAVR who were treated with RenalGuard Therapy® (forced diuresis with matched controlled hydration delivered through RenalGuard) were compared to a matched historical control cohort of 150 patients.
The incidence of post-procedural AKI was substantially lower in the RenalGuard-treated group (2.7%) compared to the control group (26.7%). The largest improvement was seen in patients undergoing trans-catheter aortic valve replacement (TAVR); the matched control patients experienced a 49% rate of AKI, compared to a 2% rate of AKI in patients treated with RenalGuard. In the patients treated with RenalGuard, eGFR improved following the procedure from 37 ml/min per 1.73 m2 at baseline to 39 ml/min per 1.73 m2 (p < 0.001); the net creatinine decreased from 1.85 mg/dl to 1.78 mg/dl (p < 0.001). Among the matched control group, eGFR deteriorated from a baseline value of 36.7 ml/min per 1.73 m2 to 33.2 ml/min per 1.73 m2 post procedurally (p < 0.001); the net creatinine increased from 1.88 mg/dl to 2.14 mg/dl (p < 0.001). The use of RenalGuard was independently correlated with reduced incidence of post procedural AKI compared with the control group (OR 0.06, p < 0.001). Contrast volume did not correlate with AKI in either univariate or multivariate analyses.
"In patients undergoing coronary angiography, angioplasty or TAVR, who are considered high risk to develop post-procedural AKI, forced diuresis with matched controlled hydration resulted in a significant net creatinine decrease, eGFR increase and a decrease in the incidence of AKI following PCI," said Dr. Banai. "We feel that patients who are at higher risk to develop AKI following an interventional procedure in the cath lab can benefit from the use of forced diuresis combined with matched hydration using RenalGuard, and we will continue to monitor this closely in our hospital."
"The MYTHOS and REMEDIAL II trials established that RenalGuard can reduce the incidence of acute kidney injury in at-risk patients," said Andrew Halpert, President, RenalGuard Solutions, Inc. "The data from this most recent trial adds to the growing body of evidence that RenalGuard is more effective than standard of care in preventing this condition in cardiovascular patients undergoing procedures requiring contrast. We are particularly pleased with the results for TAVR patients. Post-procedural AKI is one of the strongest predictors of one-year mortality in these patients, so protecting these patients remains a high priority for our team."
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.