Nuwellis Receives FDA Clearance for an Additional Dual Lumen Extended Length Peripheral Catheter
“Expanding peripheral venous access options through our dELC comes at an important time, as healthcare providers work to bring ultrafiltration therapy to patients within ICU and stepdown units,” said
Nuwellis’ dELC specialty catheter is available in two lengths and provides alternative peripheral access for ultrafiltration therapy across a broad range of patient physiologies. The new 12 cm dELC has the same features as the longer 16 cm option offered by the company but eliminates the need for trimming when a shorter catheter is needed. The dELC offers the performance capabilities of a central catheter from the periphery, and its unique inner coil design ensures consistent blood flow and prevents kinking.
“The tenacity and dedication of our research and development team is driving advancements in our products and bringing Aquadex to more patients who can benefit from the therapy,” said
Aquadex is proven to simply, safely, and precisely remove excess fluid from patients suffering from fluid overload who have not responded to conventional 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. The device’s built-in, customizable hematocrit monitoring technology provides real-time measurement of percent blood volume changes that can be tailored to individual patients’ needs. A customizable fluid removal rate is particularly important for pediatric patients, who have a small amount of blood in their bodies. The Aquadex system is cleared by the FDA for use in adults and pediatric patients weighing 20 kg (44 lbs.) or more.
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in
About the Aquadex SmartFlow® System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart 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.
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