Abington Hospital Begins a 344 Patient Retrospective Clinical Study to Analyze Experience with CHF Solutions’ Aquadex FlexF...
October 24 2019 - 8:00AM
CHF Solutions (Nasdaq: CHFS) today announced that investigators at
Abington Hospital-Jefferson Health in Abington, Pennsylvania are
conducting a retrospective analysis of their experience using the
company’s Aquadex FlexFlow System in heart failure patients with
fluid overload.
The study, titled “Retrospective Review of a Single Center
Experience with Aquapheresis in the Treatment of 344 Heart Failure
Patients with Volume Overload,” is designed to identify patient
characteristics, ultrafiltration rates, and renal function response
to the utilization of aquapheresis therapy with the Aquadex
FlexFlow system. The Abington-Jefferson Health Principal
Investigators, Robert Watson, MD, chief of Cardiology and
co-director of the Comprehensive Heart Failure program and Donald
Haas, MD, medical director, Ventricular Assist Device Program,
co-director, Comprehensive Heart Failure Program along with the
Sub-Investigators Maureen Hummel, CRNP and Patricia Barrella, RN,
MSN are conducting the analysis with the intention of publishing
their findings in a peer-reviewed medical journal. Dr. Haas noted,
“In our experience of 10 years performing ultrafiltration via
Aquadex, we have appreciated a significant benefit for many
patients with marked refractory volume overload when properly
selected. The question that exists for many institutions is which
patient will benefit and how does the clinician select the
appropriate rate of fluid removal to achieve decongestion while
preserving renal function. We hope that this retrospective review
of 344 patients will highlight the patient selection criteria and
ultrafiltration rates associated with safe and effective mechanical
decongestion in heart failure patients.”
“Regular analysis of professional experience with our Aquadex
FlexFlow system is helpful to healthcare providers to better
understand optimal management of fluid overload and use of our
system,” said John Erb, chairman and CEO of CHF Solutions.
“We are grateful to Drs. Watson and Haas and the Sub-Investigators
for studying their center’s experience with Aquadex FlexFlow and
look forward to helping other care providers learn from their
findings.”
Abington Hospital, founded in 1914, is the largest community
teaching hospital in Montgomery and Bucks counties in Pennsylvania.
Staff members have the privilege of working with medical students,
residents and fellows from Thomas Jefferson University's Sidney
Kimmel Medical College and other medical schools and training
programs in the Philadelphia area. Each year, Abington- Jefferson
Health treats over 123,000 patients in its two Emergency
Departments with Abington Hospital having the distinction of having
one of only two Level II trauma centers in Montgomery County.
Abington Hospital – Jefferson Health has a comprehensive stroke
center and offers highly advanced programs in cancer, cardiac and
orthopedic care.
About CHF SolutionsCHF Solutions, Inc.
(Nasdaq:CHFS) is a medical device company dedicated to changing the
lives of patients suffering from fluid overload through science,
collaboration, and innovative technology. The company is focused on
developing, manufacturing, and commercializing the Aquadex FlexFlow
system 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 Aquadex FlexFlow® System The Aquadex
FlexFlow system is a clinically proven therapy that provides a
safe, effective, and predictable method of removing excess fluid
from patients suffering from fluid overload. The Aquadex FlexFlow
system is indicated for temporary (up to eight hours)
ultrafiltration treatment of patients with fluid overload who have
failed diuretic therapy, and for extended (longer than 8 hours)
ultrafiltration treatment of patients with fluid overload who have
failed diuretic therapy and require hospitalization. The company
has submitted an application to the FDA requesting for 510(k)
clearance of the Aquadex FlexFlow system to include pediatric
patients who weigh 20kg or more. All treatments must be
administered by a healthcare provider, under physician
prescription, both of whom having received training in
extracorporeal therapies.
Forward-Looking StatementsCertain statements in
this release are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, including
without limitation, statements regarding the results of the
restrospective study. 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 commercialization 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-or- Bret Shapiro Managing Partner CORE IR
516-222-2560 brets@coreir.com www.coreir.com
MEDIA Jules Abraham JQA Partners, Inc.
917-885-7378 jabraham@jqapartners.com
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