Clinical Trial results demonstrating the effectiveness of RenalGuard® in preventing kidney injury to be presented at EuroPCR 2016
MILFORD, RenalGuard Solutions™, Inc., an innovative renal protection company, today announced that a retrospective study of patients using RenalGuard System™ will be presented at EuroPCR 2016, the annual meeting of the European Association for Percutaneous Cardiovascular Interventions (EAPCI), May 16-20, 2016 in Paris, France. In addition, Prof. Horst Sievert, co-PI of the STRENGTH trial, which is evaluating the long-term impact of RenalGuard Therapy®, will discuss the design of the trial on Thursday, May 19th as part of the session "Planned and ongoing clinical trials: a status update from Cardiovascular European Research Center (CERC)." The Company will demonstrate RenalGuard®, its innovative solution for protecting kidneys during interventional procedures requiring contrast, in Booth M19 on the second level of the Palais des Congrès de Paris during the conference.
The study, Value of the RenalGuard system in coronary interventions, demonstrated that RenalGuard Therapy is effective in the prevention of the deterioration of kidney functions during coronary interventions including complex PCI. The abstract, POS0574, will be presented during the poster sessions.
The single-center retrospective cohort study of all patients who were treated with RenalGuard System during coronary angiography/intervention during the year 2014-2015 was conducted at Kettering General Hospital, Kettering, United Kingdom. The primary endpoint was one-week and one-month follow-up of kidney functions post procedure. The patients received an average contrast volume of 244±8.5 ml during coronary procedures. At baseline, 48.3% of patients had grade IV renal impairment (GFR 29.9-15 ml/min/1.73 m2) and 31% had grade IIIb renal impairment (GFR 30-44.9 ml/min/1.73 m2).
The one-month follow-up showed improvement of the kidney functions from grade IV to grade IIIb, as 34.4% of the patients had grade IV renal impairment and 41.4% had grade IIIb renal impairment (OR [95% CI] 0.87 (0.57-6.10), p=0.30). No patients had grade V nephropathy (GFR of <15 ml/min/1.73 m2) at baseline or post coronary intervention. The patients who had grade IIIa renal impairment (GFR 45-59.9 ml/min/1.73 m2) were 6.9% pre-procedure and at one-month follow-up.
"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's ability to prevent acute kidney injury in the short term can lead to long-term improvements in patients' renal condition. We know that worsening renal function predicts very poor long-term outcomes. If we can actually improve renal function, as this data demonstrates, we should see improvement in patients' long-term outcomes as well."
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 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.