Nuwellis Receives FDA Clearance for an Additional Dual Lumen Extended Length Peripheral Catheter
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The FDA clearance of Nuwellis, Inc.'s specialty peripheral dual lumen extended length catheter (dELC) represents a significant advancement in the medical device sector, specifically in the treatment of fluid overload conditions such as heart failure and critical illnesses. The development of this catheter is a testament to the company's innovation, potentially addressing an unmet need within the patient population that requires ultrafiltration therapy but may not be suitable for central venous catheterization due to various physiological factors.
The introduction of the 12 cm dELC expands the usability of the Aquadex® ultrafiltration system, providing a less invasive option with the same performance as the longer 16 cm catheter without the need for trimming. This could lead to increased adoption rates of the Aquadex system, as it simplifies the process for healthcare providers and improves patient comfort. The inner coil design that prevents kinking is a technical enhancement that may contribute to consistent blood flow, which is crucial for the effectiveness of ultrafiltration therapy.
From a financial perspective, the clearance could potentially lead to increased market share and revenue growth for Nuwellis, as the expanded product line meets the needs of a broader patient demographic. However, the actual impact on the company's financials will depend on the healthcare providers' adoption rate and the ability of Nuwellis to effectively market and distribute the new catheter.
The FDA's swift clearance of Nuwellis' dELC catheter underlines the regulatory body's support for innovations that enhance patient care, particularly in critical care settings such as ICUs and stepdown units. The clearance is not only a milestone for Nuwellis but also for the healthcare industry, as it underscores the ongoing shift towards personalized medicine and the importance of having a variety of treatment options to cater to different patient physiologies.
The ability of the Aquadex system to provide real-time hematocrit monitoring and customizable fluid removal rates aligns with the industry's focus on precision medicine. For pediatric patients, in particular, the ability to tailor the rate of fluid removal is critical due to their smaller blood volume. This level of customization and monitoring can lead to improved outcomes and reduced complications, which are key factors in value-based healthcare models.
In the broader context, the impact of such advancements may encourage further investment and innovation within the medical device industry, as companies strive to address the complex needs of diverse patient populations. However, it is essential to monitor post-market performance to ensure that the benefits observed in clinical settings translate into real-world effectiveness and safety.
Fluid overload is a common complication in patients with heart failure and other critical illnesses and managing this condition is crucial for patient outcomes. The introduction of the 12 cm dELC provides a tailored approach to venous access, which is particularly beneficial for patients with limited central venous access or those for whom a central line would pose additional risks. The peripheral access offered by the dELC could reduce the incidence of line-related complications, which are of particular concern in patients with compromised health.
The Aquadex system's built-in hematocrit monitoring capability is a critical feature that allows for the real-time adjustment of fluid removal, potentially reducing the risk of hemodynamic instability during ultrafiltration therapy. This is especially important in the management of critically ill patients, where fluid balance must be meticulously controlled.
While the dELC catheter and the Aquadex system provide a promising alternative for fluid management, further clinical data may be required to validate the long-term benefits and potential risks associated with their use. As with any medical intervention, the adoption of new technologies must be balanced with a thorough understanding of patient-specific factors and potential outcomes.
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.
About Nuwellis
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 Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or Twitter.
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.
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 2024 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 impact of the COVID-19 pandemic, 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.
CONTACTS
Investors:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com
Media:
Health+Commerce
nuwellis@healthandcommerce.com
FAQ
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