Nuwellis (NSDQ:NUWE) announced today that it received CE mark approval for its 24-hour blood circuit set to be used with the Aquadex SmartFlow.
Eden Prairie, Minnesota-based Nuwellis — formerly CHF Solutions — can now market the 24-hour blood circuit set (UF 500-24 Hour) in the European Union and in other locations that recognize the CE mark.
According to a news release, the new device offers expanded access to ultrafiltration among patients who need no more than 24 hours of Aquadex therapy in the inpatient setting. Aquadex, a fluid management system that uses ultrafiltration to restore fluid balance in patients experiencing fluid overload, most recently received FDA 510(k) clearance for use in pediatric patients weighing 20 kg or more. Beyond treating heart failure, the device can be used in these situations with pediatric patients and in critical care.
The circuit can also provide a more economical solution for hospitals treating patients in the outpatient/ambulatory setting where therapy can be delivered for up to eight hours, Nuwellis said.
“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,” Nuwellis president & CEO Nestor Jaramillo, Jr. said in the release. “Receiving CE certification for the 24-hour Aquadex circuit will make outpatient ultrafiltration treatment more accessible for patients not responding to oral diuretics who may be at risk of hospitalization.”