CHF Solutions Announces Data Demonstrating Benefit of Aquadex Therapy for Treatment of Heart Failure and COVID-19
October 07 2020 - 8:00AM
CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to
changing the lives of patients suffering from fluid overload, today
announced data from a retrospective study and a case study
supporting the benefit of Aquadex™ therapy in the treatment of
heart failure. These data were presented at the 24th Annual
Scientific Meeting of Heart Failure Society of America.
The real-world retrospective study of 335 patients treated with
the Aquadex FlexFlow® System, “10 years of real world data with UF
for ADHF patients,”1 compared previous RCT trials with
ultrafiltration (UF) and demonstrated that UF compares favorably in
reducing heart failure (HF) rehospitalizations, renal function
response, and weight/volume loss. Specific results included:
- Substantial mean fluid removal (14.58 liters) and weight loss
(15.63 lbs), which was sustained at 1-2 weeks post follow-up.
- Improvement in reduced HF rehospitalization rates at 30, 90
days, and 1 year of 12.4%, 14.9%, 27.3% respectively.
- Mean serum creatinine (sCr) increase of +0.07-0.11 mg/dl
recorded at time of stopping therapy, discharge, and follow
up.
- On average, patients had 1.74 fewer hospitalizations for HF in
the year following UF when compared to the year preceding UF.
- Major bleeding, defined as requiring discontinuation of
anticoagulation, was 3.6 %
In comparison to previous randomized control trials focused on
UF (AVOID2, CARRESS3, DOSE4, and UNLOAD5), patients in this study
were older with worse renal function and greater HF
hospitalizations in the year preceding UF therapy. The ability to
adjust the rate of fluid removal with the Aquadex system is
believed to be a major contributor to favorable outcomes. The study
was conducted by Abington Hospital – Jefferson Health in Abington,
Pennsylvania and funded by CHF Solutions.
The case study, “Outpatient Ultrafiltration to Prevent Hospital
Readmissions During COVID-19 Pandemic in Diuretic Intolerant
Patient: Case Study,”6 involved the successful outpatient treatment
of a 70-year-old female with heart failure with preserved ejection
fraction and pre- and post-capillary pulmonary hypertension. This
patient did not respond to outpatient therapies and diuretics and
experienced multiple hospitalizations due to recurrent congestion.
Given the patient’s co-morbidities and high-risk status, the
patient received UF treatment with the Aquadex SmartFlow™ system in
an outpatient setting to avoid exposure to COVID-19. Over the
course of 4 days, a total of 4950 ml of isotonic fluid was removed.
The patient showed immediate improvement in clinical symptoms and
was effectively stabilized in the outpatient setting at Advocate
Good Samaritan Hospital in Downers Grove, Illinois.
“We are pleased with the results of these two studies confirming
the benefits of Aquadex therapy in the treatment of heart failure
patients, as demonstrated in previous studies and clinical
observations, and the effectiveness of use in the outpatient
setting to limit exposure to COVID-19,” said John Erb, Chairman and
CEO of CHF Solutions. “We thank the teams at Abington Hospital –
Jefferson Health and Advocate Good Samaritan Hospital for
furthering data on the benefits of ultrafiltration.”
-
https://www.chf-solutions.com/aquadex-smartflow-system/clinical-evidence/
- AVOID-HF Trial:
https://pubmed.ncbi.nlm.nih.gov/26519995/
- CARRESS-HF Trial:
https://www.nejm.org/doi/full/10.1056/NEJMoa1210357
- DOSE Trial:
https://pubmed.ncbi.nlm.nih.gov/21366472/
- UNLOAD Trial:
https://pubmed.ncbi.nlm.nih.gov/17291932/
-
https://www.chf-solutions.com/aquadex-smartflow-system/clinical-evidence/
About CHF Solutions
CHF Solutions, Inc. (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 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 about the use of Aquadex therapy in the
treatment of heart failure and COVID-19. 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 expectations regarding
the potential impacts of the COVID-19 pandemic on our business
operations, 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. 952-345-4205ir@chf-solutions.com
MEDIA:
Jessica
StebingHealth+Commerce260-336-6202jstebing@healthandcommerce.com
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