Nuwellis Receives FDA Clearance for an Additional Dual Lumen Extended Length Peripheral Catheter
January 04 2024 - 3:05PM
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 NuwellisNuwellis, 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®
SystemThe 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 StatementsCertain 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 CervantesGilmartin
Groupir@nuwellis.com
Media:Health+Commercenuwellis@healthandcommerce.com
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