CHF Solutions Announces Meta-Analysis Demonstrates Ultrafiltration is Better than Diuretic Therapy for the Management of Volu...
December 15 2020 - 8:00AM
CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to
changing the lives of patients suffering from fluid overload, today
announced a meta-analysis published in Heart Failure Reviews
concludes that ultrafiltration (UF) increases fluid removal and
weight loss and reduces rehospitalization and the risk of worsening
heart failure in congestive patients, suggesting ultrafiltration as
a safe and effective treatment option for volume-overload heart
failure patients.
When hospitalized, 88% of patients with acute decompensated
heart failure (ADHF) are treated with diuretics, yet many have
suboptimal responses (diuretic resistance, electrolyte imbalances,
deteriorating renal function). One in four of patients are
re-hospitalized within 30 days. 1
The article, “Ultrafiltration is better than diuretic therapy
for volume-overloaded acute heart failure patients: A
meta-analysis,” included eight randomized controlled studies
involving 801 ADHF patients. The authors investigated possible
advantages of UF compared to diuretic treatment regarding fluid
removal, weight loss, rehospitalization for heart failure and
all-cause mortality. Data from the analysis demonstrated:
- UF was statistically better than diuretics in terms of
increased fluid removal and weight loss.
- UF resulted in statistically significant decreases in worsening
heart failure.
- A reduction of heart failure rehospitalization with the use of
UF was sustained between 30 days and 1 year.
- No statistically significant difference between therapies in
renal impairment and all-cause mortality.
- UF is a safe and effective treatment option for
volume-overloaded ADHF patients.
“While most patients with heart failure are treated with
diuretics, only part of them attain the desired pharmacological
targets, and a significant portion of patients display suboptimal
response with persistent overhydration, poor outcomes and high
hospital readmission rates,” said Dr. Claudio Ronco, Full Professor
at the University of Padova, Italy and Director of the
International Renal Research Institute of Vicenza and Department of
Nephrology at San Bortolo Hospital in Vicenza, Italy.
"As demonstrated by this recent publication, the only chance to
adequately manage overhydration in several patients is to use
extracorporeal mechanical ultrafiltration. With this technique,
fluid management becomes easy and effective with marginal or absent
unwanted effects. The treatment results in a lower rate of
hospitalization and improved quality of life for heart failure
patients.” Conclusions from this meta-analysis are
consistent with findings from the real-world retrospective study of
335 patients treated with the Aquadex FlexFlow® System, presented
at the 24th Annual Scientific Meeting of Heart Failure Society of
America. Data demonstrate that UF is safe and effective, comparing
favorably in reducing heart failure rehospitalizations, renal
function response, and weight/volume loss.2
“Our mission is to improve outcomes for people suffering from
fluid overload, and this meta-analysis further demonstrates how
ultrafiltration is capable of doing so,” said John Erb, Chairman
and CEO of CHF Solutions. “This analysis is a welcome addition to
the growing list of evidence supporting the numerous benefits of
ultrafiltration and the Aquadex™ technology.”
- Wobbe, B., Wagner, J., Szabo, D.K.,
et. al. Ultrafiltration is better than diuretic therapy for
volume-overloaded acute heart failure patients: a meta-analysis.
Heart Fail. Rev. (2020)
https://doi.org/10.1007/s10741-020-10057-7
-
https://www.chf-solutions.com/aquadex-smartflow-system/clinical-evidence/
About Meta-analysisA meta-analysis is a
statistical analysis that combines study data from multiple
independent studies (e.g. randomized studies) with a specific
question, which aims to generate statistical significance and an
average effect. A key benefit of a meta-analysis is that the
aggregation of data leads to a higher statistical power, and more
robust point estimate than is possible from an individual
study.
About CHF Solutions CHF Solutions, Inc.
(Nasdaq: CHFS) is a medical device company dedicated to improving
the lives of patients suffering from fluid overload with its novel
ultrafiltration therapy system. The company is focused on
developing, manufacturing and commercializing the Aquadex SmartFlow
system for ultrafiltration therapy. CHF Solutions is headquartered
in Minneapolis, Minn., 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 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 use of
the Aquadex SmartFlow system to treat pediatric patients.
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 Drayton
Chief Financial Officer, CHF Solutions, Inc.
952-345-4205
ir@chf-solutions.com
Matt Bacso, CFA
Gilmartin Group LLC
Matt.bacso@gilmartinir.com
MEDIA:
Jessica Stebing
Health+Commerce
260-336-6202
jstebing@healthandcommerce.com
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