Nuwellis Receives FDA Clearance for an Additional Dual Lumen Extended Length Peripheral Catheter
Specialty catheter provides alternative peripheral access for ultrafiltration therapy across a greater range of patient physiologies
MINNEAPOLIS, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its specialty peripheral dual lumen extended length catheter (dELC). The addition of a new 12 cm catheter provides clinicians who treat patients with fluid overload with an additional venous access option to use the company’s Aquadex® ultrafiltration system.
“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 Nestor Jaramillo, Jr., President and Chief Executive Officer of Nuwellis. “Our unwavering commitment is to make Aquadex safe, effective, and easy to administer to the countless patients suffering from fluid overload, because of heart failure or critical illnesses, in our healthcare systems.”
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 Vitaliy Epshteyn, Nuwellis’ Senior Vice President of Operations, Engineering, Quality, and Regulatory. “We extend our gratitude to the FDA for its swift review and clearance of the dELC catheter, marking a significant milestone on our mission to transform fluid management.”
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.
