National Institutes of Health Begins Study of CHF Solutions' Aquapheresis(TM) Therapy

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Tue Sep 2, 2008 8:00am EDT

Study to Evaluate Aquapheresis Versus Standard Drug Therapy in
 Patients Hospitalized with Both Acute Decompensated Heart Failure and
                         CardioRenal Syndrome
BROOKLYN PARK, Minn.--(Business Wire)--
The National Institutes of Health (NIH) has informed CHF
Solutions, Inc. that the CARRESS-HF trial has begun enrolling
patients. Sponsored by NIH's National Heart, Lung, and Blood Institute
and chosen out of 16 national submissions for studies in heart
failure, this study will compare CHF Solutions' unique Aquapheresis
therapy with standard medical drug therapy in patients hospitalized
with acute decompensated heart failure (ADHF) and cardiorenal
syndrome.

   The CARdiorenal REScue Study in Acute Decompensated Heart Failure,
or CARRESS-HF study, is open to NIH centers and is a randomized,
multi-center, 200- patient trial that is testing if Aquapheresis
therapy in hospitalized ADHF patients with cardiorenal syndrome
results in improved renal function and relief of congestion compared
to stepped pharmacologic care. It is estimated that CardioRenal
syndrome occurs in 25 percent of the millions of hospitalized Acute
Heart Failure (AHF) patients each year.

   "I believe that CARRESS is a very important trial," describes Dr.
Eugene Braunwald, Distinguished Hersey Professor of Medicine at
Harvard Medical School. "I look forward to the results which can have
an important impact on the care of seriously ill patients with heart
failure."

   Duke University is the data coordinating center for the trial.
Participating are nine Regional Heart Failure Consortiums comprising
more than 25 medical centers throughout the United States and Canada.
Some of these centers include: Brigham and Women's Hospital, Mayo
Clinic, Minnesota Heart Failure Network, Duke University Medical
Center, Baylor College of Medicine, University of Utah, University of
Vermont, and the Montreal Heart Institute. Detailed information about
the study can be found at the U.S. National Institutes of Health
Clinical Trials website at the following address:
http://clinicaltrial.gov/ct2/show/NCT00608491?term=CARRESS

   About Heart Failure and CardioRenal Syndrome

   Heart failure is a serious condition in which the heart's ability
to pump blood through the body is impaired, often making a person feel
weak or fatigued. When a person's condition worsens to the point of
hospitalization, that person is said to have acute decompensated heart
failure (ADHF). Abnormal kidney function in association with cardiac
distress (known as cardiorenal syndrome) is a common complication of
heart failure and the drug based therapies used to treat it. Further
medical problems and the need for hospitalization are currently common
outcomes. While there are various treatments for heart failure,
research is needed to determine the best treatment for targeting both
ADHF and cardiorenal syndrome.

   About Fluid Overload and Aquapheresis(TM)

   Fluid overload can be caused by problems with the heart, kidneys,
liver and lungs, and is frequently experienced after surgical
operations, trauma, and burns. The leading cause of fluid overload is
congestive heart failure (CHF), sometimes referred as just heart
failure. Heart failure is a condition that affects approximately 5
million Americans and is responsible for over 3.1 million primary and
secondary hospitalizations annually.

   CHF Solutions' Aquapheresis therapy is a mechanical method to
safely and effectively remove the excess salt and water in patients
with fluid overload. Aquapheresis is currently available at more than
250 leading medical centers and outpatient clinics worldwide. To date,
over 15,000 patients have received therapy.

   About CHF Solutions

   CHF Solutions, based in Brooklyn Park, Minn., is a privately held
manufacturer of medical devices for cardiac care. The company's
mission is to provide medical practitioners with innovative and
practical solutions that enable the treatment of patients with unmet
clinical needs. For more information, go to www.chfsolutions.com and
www.unloadstudy.com.

Padilla Speer Beardsley Inc.
Nancy A. Johnson, 612-455-1745
njohnson@psbpr.com
or
Nick Banovetz, 612-455-1705
nbanovetz@psbpr.com
or
CHF Solutions, Inc.
Ed Rychlick, 763-463-4671
rychlick@chfsolutions.com

Copyright Business Wire 2008
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