First-in-Man Feasibility Study Evaluates RenalGuard System to Manage Fluids in Heart Failure Patients
January 5, 2018—RenalGuard Solutions, Inc. announced positive results from a first-in-man (FIM) feasibility study focusing on a novel use of the company's RenalGuard system to manage fluids during diuretic therapy in congestive heart failure patients experiencing fluid overload.
The company noted that the RenalGuard system was originally developed to protect patients from acute kidney injury (AKI), including contrast-induced (CI) AKI. It has received CE Mark approval and is commercially available in Europe for CI AKI. A pivotal study is underway in the United States to support a planned premarket approval filing with the US Food and Drug Administration in 2018 for the prevention of CI AKI.
The RenalGuard system measures a patient’s urine output, then infuses a volume of saline to maintain the desired fluid balance. The clinician can set a maximum fluid-loss rate, beyond which RenalGuard will not allow the patient’s fluid balance to drop, thus limiting the potential for excessive fluid loss. This may allow clinicians to increase the dose of diuretic without increasing the risk of diuretic resistance.
The recently presented FIM results followed the treatment of 10 diuretic-resistant patients with heart failure symptoms receiving diuretic therapy while their fluid management was controlled by the RenalGuard system.
Prof. Piotr Ponikowski, MD, and Prof. Felix Mahfoud, MD, presented the findings at the annual Devices in Heart Failure Congress, which was held December 15–16 in Berlin, Germany. Prof. Ponikowski is with the Wroclaw Medical University in Wroclaw, Poland, and Prof. Mahfoud is with the Saarland University Hospital in Homburg, Germany.
According to the company, the presentation reviewed the ways in which current treatment strategies for hospitalized patients with heart failure remain inadequate. Annual hospitalizations for heart failure exceed 1 million in both the United States and Europe, and more than 90% are caused by symptoms and signs of fluid overload. Recurrent fluid overload in heart failure patients has uniformly been associated with worse outcomes independent of age and renal function; 25% of hospitalized patients will be rehospitalized within 3 months, with a 1-year mortality rate of 26%.
Prof. Ponikowski and Prof. Mahfoud also identified the drawbacks of diuretic therapy, the cornerstone therapy for fluid overload, which acts primarily by inducing fluid loss. An individual patient’s response to diuretic therapy is often variable and unpredictable. If the patient sees excessive urine output caused by the diuretic, this rapid fluid loss can induce diuretic resistance, which blunts the continued function of diuretics and may result in AKI.
In the company's announcement, Prof. Ponikowski commented, “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.”
Prof. Mahfoud added, “There is a clear unmet clinical need for alternative methods of fluid removal with superior efficacy in patients with heart failure. This FIM 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.”