CHF Solutions Grabs 510(k) Clearance for Hypervolemia Device

CHF Solutions has received FDA clearance for its Aquadex SmartFlow console, a device for treatment of fluid overload (hypervolemia) in adult and pediatric patients weighing 44 pounds or more.

The clearance was based on a multi-center study of pediatric hypervolemia patients in which 97 percent of the 32 patients survived to the end of therapy.

The console can be used for extended periods for patients who haven’t responded to medical management.