RenalGuard Solutions today touted results from a first-in-man feasibility study of its RenalGuard System designed to manage fluids during diuretic therapy to treat congestive heart failure in patients suffering from fluid overload.
Results from the trial were presented at the annual Devices in Heart Failure congress in Berlin, Germany, the Milford, Mass.-based company said.
The company’s RenalGuard device is designed to measure urine output and automatically infuse hydration fluid based on those measurements, aiming to induce high urine rates to protect the kidneys, the company said.
Data from the study followed the treatment of 10 diuretic resistant patients with heart failure symptoms receiving diuretic therapy while fluid management was controlled by the RenalGuard system.
“None of the patients we treated experienced a fluid loss rate greater than the settings we established. RenalGuard Therapy is remarkably simple and safe, and works automatically to carefully achieve and control the desired fluid balance,” Dr. Piotr Ponikowski, who co-presented the results of the study, said in a prepared statement.
“There is a clear unmet clinical need for alternative methods of fluid removal with superior efficacy in patients with heart failure. This first-in-man study demonstrated that RenalGuard can safely be used in these patients while maintaining the proper conditions to both prevent diuretic resistance, and increase the removal of excess fluid from the patient. Our initial experience with the RenalGuard System in heart failure patients is very promising, and we look forward to advancing our understanding of the benefits of this therapy to patients at risk,” Dr. Felix Mahfoud, who co-presented the results of the study, said in a prepared release.
The RenalGuard system has won CE Mark approval in the European Union, and is being used in a pivotal study in the US as the company seeks premarket approval with the FDA, which it hopes to file this year.
“These presentations demonstrate that the RenalGuard Therapy is a viable potential treatment for patients suffering from fluid overload from congestive heart failure. The results add to a growing body of evidence supporting the use of RenalGuard as a platform technology to improve cardiac and renal care for a wide range of patients, including cath lab, cardiac surgery, and now congestive heart failure,” CEO Jim Dillon said in a press release.
Last March, RenalGuard said it raised a $14.5 million Series A round for a pivotal trial of its device to prevent acute kidney injury during percutaneous procedures.