CHF Solutions Announces Presentation of Clinical Data with Aquadex FlexFlow® Highlighting Efficacy and Simplicity of Use In Treating Critical Care Patients
January 08, 2020 at 01:00 pm
Share
CHF Solutions announced results from an investigator-initiated retrospective analysis of utilization of the Aquadex FlexFlow aquapheresis system at Lenox Hill Hospital in New York City. The study was presented at the American Society of Nephrology’s Kidney Week in Washington, D.C. in November 2019. The analysis looked at 23 patients who received aquapheresis treatment following cardiogenic shock, including post cardiothoracic procedure, anasarca, acute tubular necrosis (ATN) with volume overload, bridge ultrafiltration in end-stage renal disease (ESRD) between hemodialysis, and post-operative volume overload. The average duration of treatment with Aquadex FlexFlow per patient was 4.26 days. Researchers noted that, despite the significant volume removed per day (1,954 mls) and per encounter (8,323mls), there was no significant change in creatinine (an indicator of renal function). Investigators also noted the ease of using the Aquadex FlexFlow system compared to the more complicated operation of hemodialysis equipment. The Aquadex FlexFlow system is a clinically proven therapy that provides a safe, effective, and predictable method of removing excess fluid from patients suffering from fluid overload. The Aquadex FlexFlow system is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and for extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. The company has submitted an application to the FDA requesting for 510(k) clearance of the Aquadex FlexFlow system to include pediatric patients who weigh 20kg or more. All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.
Nuwellis, Inc. is a medical technology company. The Company is focused on developing, manufacturing, and commercializing medical devices used in ultrafiltration therapy, including the Aquadex FlexFlow and the Aquadex SmartFlow systems (collectively the Aquadex System). The Aquadex SmartFlow system is indicated for temporary or extended use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. The Aquadex System is designed to remove excess fluid from patients suffering from fluid overload who have failed diuretic therapy. The Aquadex System consists of a console, which is a piece of equipment containing electromechanical pumps and a liquid crystal display (LCD) screen; a one-time disposable blood circuit set, which is an integrated collection of tubing, filters, sensors, and connectors that contain and deliver the blood from and back to the patient, and a disposable catheter.
CHF Solutions Announces Presentation of Clinical Data with Aquadex FlexFlow® Highlighting Efficacy and Simplicity of Use In Treating Critical Care Patients