CHF Solutions receives 510(k) clearance for Aquadex SmartFlow™ system in Pediatric Patients Weighing 20kg or More
February 26 2020 - 8:00AM
CHF Solutions (Nasdaq: CHFS) today announced FDA 510(k) clearance
in the U.S. of its next generation Aquadex SmartFlow console for
use in adult and pediatric patients who weigh 20kg or more. The
console is a simple, gentle, and smart solution for treatment of
patients suffering from hypervolemia (fluid overload).
In a retrospective, multi-center study, 32 pediatric patients
weighing over 20 kgs and predominantly suffering from hypervolemia
were treated with the Aquadex system and 97% (31/32) survived to
the end of therapy.1
“For many types of pediatric patients, the available therapies
require very high relative extracorporeal blood volumes, which can
be challenging,” said Stuart Goldstein, M.D., Professor of
Pediatrics and Director, Center for Acute Care Nephrology at
Cincinnati Children’s Hospital Medical Center and a paid consultant
of CHF Solutions. “The Aquadex SmartFlow system allows us to
initiate therapy with excellent hemodynamic stability due to the
low extracorporeal value of 35ml. In addition, the hematocrit
monitoring feature helps caregivers maintain appropriate fluid
balance in their patients.”
“With the approval of the Aquadex SmartFlow, traditionally
underserved pediatric patients will benefit from ultrafiltration
therapy that has shown positive clinical results and has strong
interest from pediatric hospitals,” said John Erb, chairman and CEO
of CHF Solutions. “FDA clearance for pediatric patients is a
significant milestone for the company and the result of strong
execution from our team.”
About CHF Solutions
CHF Solutions, Inc. (Nasdaq:CHFS) is a medical device company
dedicated to changing the lives of patients suffering from fluid
overload through science, collaboration, and innovation. The
company is focused on developing, manufacturing, and
commercializing the Aquadex SmartFlow systems for ultrafiltration
therapy. CHF Solutions is a Delaware corporation headquartered in
Minneapolis, Minnesota with wholly owned subsidiaries in Australia
and Ireland. The company has been listed on the Nasdaq Capital
Market since February 2012.
About the Aquadex SmartFlow System
The Aquadex SmartFlow system is a clinically proven therapy that
provides 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
kilograms or more whose fluid overload is unresponsive to medical
management, including diuretics. All treatments must be
administered by a healthcare provider, within an outpatient or
inpatient clinical setting, under physician prescription, both of
whom 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 about the clinical use of the Aquadex
SmartFlow system in adult and pediatric patients weighing 20kg or
more. 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 risk associated with
our ability to execute on our commercial 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. CHF Solutions does not assume
any obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
CONTACTS:
INVESTORS:
Claudia Napal DraytonChief Financial Officer CHF Solutions,
Inc.952-345-4205ir@chf-solutions.com-or- Bret Shapiro Managing
Partner CORE IR 516-222-2560 brets@coreir.com www.coreir.com
1.
https://cjasn.asnjournals.org/content/early/2019/08/27/CJN.03240319
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