Nuwellis Receives FDA 510(k) Clearance for New Dual Lumen Extended Length Catheter
Nuwellis (Nasdaq: NUWE) has received FDA 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC). The catheter, available in 11 cm and 15 cm lengths, is designed for peripheral venous access to support ultrafiltration therapy with the Aquadex system for up to 72 hours.
The clearance advances Nuwellis' strategy to build a comprehensive fluid management platform across various care settings, from ICU to outpatient facilities. The dELC features coil reinforcement and dual-lumen design for consistent blood flow, supporting the company's focus on three growth areas: critical care, cardiac surgery recovery, and hospital-based outpatient heart failure programs.
Nuwellis (Nasdaq: NUWE) ha ottenuto la clearance FDA 510(k) per una nuova misura del suo catetere Dual Lumen Extended Length Catheter (dELC). Il dispositivo, disponibile in versioni da 11 cm e 15 cm, 猫 pensato per l'accesso venoso periferico e supporta la terapia di ultrafiltrazione con il sistema Aquadex fino a 72 ore.
Questa approvazione supporta la strategia di Nuwellis di sviluppare una piattaforma completa per la gestione dei fluidi in diversi contesti assistenziali, dall'ICU agli ambulatori. Il dELC presenta un rinforzo a spirale e un design a doppio lume che garantiscono un flusso sanguigno costante, in linea con l'attenzione dell'azienda su tre aree di crescita: terapia intensiva, recupero dopo chirurgia cardiaca e programmi ospedalieri ambulatoriali per scompenso cardiaco.
Nuwellis (Nasdaq: NUWE) ha obtenido la autorizaci贸n FDA 510(k) para un nuevo tama帽o de su cat茅ter Dual Lumen Extended Length Catheter (dELC). El cat茅ter, disponible en longitudes de 11 cm y 15 cm, est谩 dise帽ado para acceso venoso perif茅rico y permite la terapia de ultrafiltraci贸n con el sistema Aquadex durante hasta 72 horas.
La autorizaci贸n impulsa la estrategia de Nuwellis de crear una plataforma integral de manejo de fluidos en distintos entornos de atenci贸n, desde la UCI hasta centros ambulatorios. El dELC incorpora refuerzo en espiral y dise帽o de doble lumen para mantener un flujo sangu铆neo consistente, apoyando el enfoque de la compa帽铆a en tres 谩reas de crecimiento: cuidados cr铆ticos, recuperaci贸n tras cirug铆a card铆aca y programas hospitalarios ambulatorios para insuficiencia card铆aca.
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Nuwellis (Nasdaq: NUWE) a obtenu l'autorisation FDA 510(k) pour une nouvelle taille de son cath茅ter Dual Lumen Extended Length Catheter (dELC). Le cath茅ter, disponible en 11 cm et 15 cm, est destin茅 脿 l'acc猫s veineux p茅riph茅rique et permet de r茅aliser une ultrafiltration avec le syst猫me Aquadex pendant jusqu'脿 72 heures.
Cette autorisation fait progresser la strat茅gie de Nuwellis visant 脿 d茅velopper une plateforme compl猫te de gestion des fluides dans divers contextes de soins, de l'USI aux structures ambulatoires. Le dELC est renforc茅 par une h茅lice et dot茅 d'un double lumen assurant un d茅bit sanguin constant, soutenant l'accent mis par la soci茅t茅 sur trois axes de croissance : soins critiques, r茅cup茅ration apr猫s chirurgie cardiaque et programmes ambulatoires hospitaliers pour l'insuffisance cardiaque.
Nuwellis (Nasdaq: NUWE) hat f眉r eine neue Gr枚脽e seines Dual Lumen Extended Length Catheter (dELC) die FDA 510(k)-Zulassung erhalten. Der Katheter, verf眉gbar in 11 cm und 15 cm L盲ngen, ist f眉r peripheren Venen-Zugang konzipiert und unterst眉tzt die Ultrafiltrationstherapie mit dem Aquadex-System f眉r bis zu 72 Stunden.
Die Zulassung f枚rdert Nuwellis' Strategie, eine umfassende Fl眉ssigkeitsmanagement-Plattform f眉r verschiedene Versorgungsbereiche 鈥� von der Intensivstation bis zur ambulanten Versorgung 鈥� aufzubauen. Der dELC verf眉gt 眉ber eine Spiralverst盲rkung und ein Doppel-Lumen-Design f眉r gleichm盲脽igen Blutfluss und unterst眉tzt damit den Fokus des Unternehmens auf drei Wachstumsbereiche: Intensivmedizin, Erholung nach Herzoperationen und station盲re ambulante Herzinsuffizienzprogramme.
- FDA 510(k) clearance expands product portfolio with new catheter size option
- Dual-length options (11cm and 15cm) provide flexibility for different patient needs
- Product supports company's expansion across multiple care settings
- Coil-reinforced design enables consistent blood flow for up to 72 hours
- None.
Insights
Nuwellis' new catheter size clearance strengthens their fluid management platform, expanding treatment options across various care settings.
The FDA 510(k) clearance for Nuwellis' new Dual Lumen Extended Length Catheter (dELC) size represents a strategic expansion of their fluid management capabilities. This development isn't just about adding another product鈥攊t's about enhancing their comprehensive platform approach to ultrafiltration therapy.
The technical specifications are particularly significant: the coil-reinforced design helps prevent catheter kinking and collapse during ultrafiltration, while the dual-lumen configuration maintains consistent blood flow rates. With both 11 cm and 15 cm options now available, clinicians gain flexibility in treating patients with varying anatomies and vascular access challenges.
This clearance advances Nuwellis' three-pronged growth strategy targeting critical care, cardiac surgery recovery, and hospital-based outpatient heart failure programs. The catheter's 72-hour usage window strikes a balance between minimizing infection risks associated with longer-term catheters while providing sufficient treatment time.
Most importantly, this advancement bridges a crucial gap in fluid management by providing peripheral venous access with central-line performance characteristics. This means clinicians can deliver ultrafiltration therapy without resorting to central venous catheters鈥攔educing procedural complexity, potential complications, and resource utilization while maintaining treatment effectiveness.
By standardizing access across different hospital units and outpatient settings, Nuwellis is positioning its Aquadex system as a versatile solution that can follow patients throughout their care journey, potentially increasing utilization rates and driving adoption of their technology platform.
MINNEAPOLIS, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on fluid management, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC).
Advancing a broader fluid management platform:
This clearance supports Nuwellis鈥� multi-year plan to build a comprehensive fluid management platform鈥攃ombining therapy delivery, dedicated venous access, and practical implementation support鈥攕o hospitals and clinics can standardize how they identify patients, begin ultrafiltration therapy earlier, and sustain programs from the ICU to step-down and hospital-based outpatient settings. The company鈥檚 strategy centers on three growth drivers: critical care, cardiac surgery recovery, and hospital-based outpatient heart failure programs.
鈥淐linicians have asked for dependable peripheral access that works across inpatient units and emerging outpatient programs,鈥� said John Erb, Chief Executive Officer of Nuwellis. 鈥淲ith two extended lengths and coil reinforcement, the dELC helps teams match access to the patient and care setting, streamlining workflow, and delivering therapy with increased confidence. This new length is another step in strengthening our technology platform and enabling consistent, repeatable use of Aquadex across care pathways.鈥�
Why it matters for clinicians:
- Peripheral access, central-line performance 鈥� Coil reinforcement and dual-lumen design enable consistent blood flow for ultrafiltration therapy.
- Choice of lengths 鈥� 11 cm and 15 cm options help match patient size and site-of-care needs.
- Fits existing workflows 鈥� Configured for compatibility with the Aquadex SmartFlow庐 systems used in hospitalized and outpatient heart failure pathways.
Indications for Use:
The dELC is indicated for use up to 72 hours in attaining venous access for use with the Aquadex FlexFlow庐 and Aquadex SmartFlow庐 systems for ultrafiltration therapy.
The dELC is designed to provide reliable peripheral venous access to support extracorporeal fluid removal with the Aquadex庐 system, aligning with Nuwellis鈥� strategy to make precise fluid management simpler and more accessible across care settings. The cleared portfolio now includes two coil-reinforced, 6F catheters with 11 cm and 15 cm insertable lengths to accommodate a range of patient anatomies and clinical workflows.
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About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical device 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庐 system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or X, formerly known as Twitter.
About the Aquadex SmartFlow庐 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.
Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2025 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.
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