The REMEDIAL III Clinical study demonstrated that RenalGuard Therapy is more effective in preventing the composite of CI-AKI and/or acute pulmonary edema in high-risk patients
RenalGuard Solutions, a US-based medical device company, has announced positive results from the clinical trial of its RenalGuard Therapy compared to the POSEIDON method in preventing contrast-induced acute kidney injury (CI-AKI).
The randomised, investigator-driven REMEDIAL III clinical study enrolled 700 patients with kidney disease who undergo interventional procedures.
RenalGuard President and CEO Jim Dillon said: “We congratulate Dr. Briguori and his team on completing the largest study to date involving the RenalGuard System.
A growing body of clinical evidence shows that core vital organs are protected by both the RenalGuard system and affiliate company Reprieve Cardiovascular’s automated diuresis system. Both of these targeted therapies correct fluid imbalances to optimize outcomes for the growing population of patients with cardiac and renal disease.”
RenalGuard Therapy and POSEIDON method are the two patient specific hydration regimens
The contrast used in interventional procedures result in injuring the kidney in several ways, including direct toxicity, blocking oxygen delivery to the kidney, and increasing fluid loss.
REMEDIAL III trial was intended to evaluate the capability of RenalGuard Therapy compared to left ventricular end-diastolic pressure (LVEDP)-guided hydration, the POSEIDON method, to protect at-risk patients from CI-AKI.
The company said that its RenalGuard Therapy is designed to protect patients by inducing and maintaining high urine output, and various clinical trials showed that the high urine output induced would reduce the incidence of CI-AKI.
In addition, the study results demonstrated that RenalGuard Therapy is more effective in preventing the composite of CI-AKI and/or acute pulmonary edema in high-risk patients, compared to LVEDP-guided hydration.
RenalGuard Solutions chief medical officer Howard Levin said: “RenalGuard Therapy has once again been proven to be the most effective means of preventing acute kidney injury in at risk patients.
“In comparing RenalGuard to the POSEIDON protocol, Dr. Briguori selected the most aggressive comparison possible. His finding that RenalGuard provided superior CI-AKI protection provides the strongest evidence to date to support the use of RenalGuard Therapy in at-risk patients.”