CHF Solutions (NSDQ:CHFS) announced today that it received FDA 510(k) clearance for its next-generation Aquadex SmartFlow console for use in adult and pediatric patients weighing 20 kg or more.
Eden Prairie, Minn.–based CHF Solutions said it submitted an application for clearance for the next-generation console last month, having previously offered its Aquadex FlexFlow system that wasn’t indicated for pediatric patients.
The Aquadex SmartFlow system is designed to remove excess fluid from patients suffering from hypervolemia (fluid overload). It is indicated for temporary (up to eight hours) of ultrafiltration treatment for patients who have failed diuretic therapy and for extended (more than eight hours) in patients who failed diuretic therapy and require hospitalization.
According to a news release, a study showed that, of 32 pediatric patients weighing over 20 kg and predominantly suffering from hypervolemia who were treated with the Aquadex SmartFlow system, 97% (31 out of 32) survived to the end of therapy.
Director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center and paid consultant of CHF Solutions Dr. Stuart Goldstein said in the news release that the Aquadex SmartFlow system allows the initiation of therapy with “excellent” hemodynamic stability and helps caregivers maintain the appropriate fluid balance in patients.
“With the approval of the Aquadex SmartFlow, traditionally underserved pediatric patients will benefit from ultrafiltration therapy that has shown positive clinical results and has strong interest from pediatric hospitals,” CHF Solutions chairman & CEO John Erb said in the news release. “FDA clearance for pediatric patients is a significant milestone for the company and the result of strong execution from our team.”