Nuwellis Gains FDA Clearance for Advanced Catheter Technology
Nuwellis Achieves FDA Clearance for Revolutionary Catheter
Nuwellis, Inc. (Nasdaq: NUWE), based in Minneapolis, is making significant strides in fluid management technologies. The company has proudly announced its attainment of FDA 510(k) clearance for a new variant of the Dual Lumen Extended Length Catheter (dELC), designed to enhance patient care.
Enhancing Fluid Management Platform
This new clearance aligns with Nuwellis’ ongoing ambitions to develop a comprehensive fluid management platform. This strategically integrated approach assists hospitals and outpatient facilities in standardizing the administration of ultrafiltration therapy. Nuwellis aims to facilitate a seamless transition from intensive care to outpatient treatments, thereby ensuring efficient patient management.
Core Strategy for Growth
The company forwards a robust growth strategy focusing on three primary sectors: critical care, cardiac surgical recovery, and hospital-based outpatient heart failure programs. By harnessing a cohesive therapy approach, Nuwellis positions itself as a leader in the medical technology arena.
An Innovative Solution for Clinicians
CEO John Erb states, "Clinicians have expressed a need for reliable peripheral access that transcends inpatient units to address emerging outpatient programs." With two extended lengths available and structural coil reinforcement, the dELC aligns with patient requirements and operational workflows, ensuring the effective delivery of therapy and confidence in procedures.
The Importance of dELC for Healthcare Professionals
The dELC offers vital benefits for healthcare professionals, allowing for:
- Reliable Peripheral Access: The dual-lumen structure alongside coil reinforcement ensures a consistent blood flow, essential for ultrafiltration therapy.
- Length Variations: Featuring 11 cm and 15 cm lengths, this catheter addresses diverse patient anatomical considerations and care settings.
- Workflow Compatibility: Designed for ease of integration with the Aquadex SmartFlow® systems currently employed in both inpatient and outpatient heart care environments.
Indications and Use
The dELC is specifically intended for a clinical use period of up to 72 hours, serving as a reliable venous access route for patients receiving ultrafiltration therapy through the Aquadex FlexFlow® and SmartFlow® systems. Its design ensures it meets Nuwellis' commitment to making fluid management more effective and accessible across various healthcare settings.
Aquadex SmartFlow® System Overview
The Aquadex SmartFlow system is pivotal for facilitating the removal of excess bodily fluid for those battling hypervolemia, where traditional medical management options are ineffective. It is suitable for both adults and pediatric patients, emphasizing the flexibility and efficacy of the technology.
Training and Administration
All procedures involving the Aquadex SmartFlow system must be conducted under the supervision of trained health care professionals in clinical settings, ensuring patient safety and optimal care outcomes.
About Nuwellis
Nuwellis is a dedicated medical device enterprise committed to innovating treatment options for patients facing challenges associated with fluid overload. The company not only focuses on enhancing the Aquadex SmartFlow system but also remains actively engaged in developing additional technologies for fluid management.
Frequently Asked Questions
What is the Dual Lumen Extended Length Catheter used for?
It is utilized for achieving reliable venous access in ultrafiltration therapy, enhancing patient care in various clinical settings.
Who can use the Aquadex SmartFlow® system?
The system is indicated for both adult and pediatric patients weighing 20 kg or more, who have fluid overload conditions unresponsive to other treatments.
How long can the dELC be utilized on a patient?
The catheter can be safely used for up to 72 hours to provide venous access for ultrafiltration therapy.
What are the notable features of the dELC?
Its coil reinforcement allows for stable and consistent blood flow, with two available lengths (11 cm and 15 cm) to suit patient needs.
What is the overall goal of Nuwellis?
Nuwellis strives to revolutionize fluid management through innovative technology, ensuring better clinical outcomes for patients suffering from fluid overload.
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