Nuwellis Receives CE Mark for 24-Hour Blood Circuit Set
The new device will help Nuwellis expand access to ultrafiltration among patients who need no more than 24 hours of Aquadex therapy in the inpatient setting. Additionally, this circuit can provide a more economical solution for hospitals to treat patients in the outpatient/ambulatory setting, where therapy can be delivered for up to 8 hours. Such use in the outpatient setting provides Nuwellis the flexibility to better meet the clinical and healthcare economic needs of European markets, while at the same time improving lives by seeking to prevent hospitalizations.
“For the past two years, we have watched hospitals around the world experience tremendous capacity pressures, which has further emphasized the important role that the ambulatory setting can play in patient care,” said
The Aquadex SmartFlow System simply, safely, and precisely removes excess fluid (primarily salt and water) from patients suffering from fluid overload who have not responded to medical management, including diuretics. Providers can specify and adjust the rate of fluid removed for each individual patient, resulting in a gradual reduction of excess fluid. Up to 500 mL per hour of excess fluid can be removed.
The 24-hour blood circuit is part of the Aquadex SmartFlow system, which consists of three components:
- The console, which allows caregivers precise control of ultrafiltration therapy.
- The peripheral catheter, which draws blood from and returns blood to the patient.
- The blood circuit set, which filters the patient’s blood and collects excess water and salt.
Ambulatory care is one of the fastest-growing and highest-margin segments of the healthcare industry, according to a 2020 study by
About the Aquadex SmartFlow System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and predictable method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.
George MontagueCFO, Nuwellis, IncIR@nuwellis.com Media Contact: Laurel HoodHealth+Commerce firstname.lastname@example.org
Source: Nuwellis, Inc.