CHF Solutions, a private medical device manufacturer, announced today that the Minnesota Heart Failure Consortium (MHFC), a non-profit research organization based in Minneapolis, has launched a clinical study of the company's System 100 Fluid Removal System, a mechanical pump/ultrafiltration system that removes excess fluid from fluid-overloaded patients. Called RAPID CHF (Randomized Control Trial of Ultrafiltration for Decompensated Congestive Heart Failure), the study is designed to demonstrate the efficacy of ultrafiltration versus the best medical therapy drugs in hospitalized congestive heart failure patients with fluid overload. In these patients, an inefficient heart can lead to a buildup of excess fluid, causing swollen legs and arms and eventually severe shortness of breath and fatigue.
"MHFC is focused on congestive heart failure, and we are especially pleased that the consortium has undertaken this study," said John L. Erb, CHF Solutions president and chief executive officer. "Previous studies have demonstrated the clinical efficacy of the System 100. We have more to learn about how to reap the maximum patient benefits from this new technology."
"Heart failure is a huge public health problem that impacts a patient's quality of life and is expensive to treat," said Dr. Bradley Bart, principal investigator of the RAPID CHF study and director of Nuclear Cardiac Imaging at Hennepin County Medical Center, Minneapolis. "The System 100 may change the way physicians treat patients with heart failure. Fluid removal with diuretics can be unpredictable, and dialysis is expensive and requires special nursing care. If the ultrafiltration device is faster, then the implication is that the patient will feel better faster and go home sooner."
The RAPID CHF study is assessing several measures of clinical efficacy, including total weight loss, quality of life, level of CHF disease classification, length of hospital stay and blood chemistry changes before, during and 30 days after treatment. The RAPID CHF study is under way at six Minneapolis/St.Paul-based hospitals and will enroll 40 patients. For more information on the RAPID CHF study, please contact Shari Mackendanz at (612) 347-5126.
About the System 100
The System 100 is a technologically sophisticated - yet easy to use - mechanical pump/ultrafiltration system that can remove up to four liters (one gallon) of excess fluid from the body over eight hours. Conventional diuretic treatment typically takes several days. Physicians can specify and adjust the amount and rate of fluid to be removed, with no clinically significant impact on blood chemistry, blood pressure or heart rate. A standard catheter inserted into a peripheral or central vein connects the patient to the CHF Solutions System 100. The company recently received an additional 510(k) market clearance for central venous access and a dual lumen extended length catheter from the Food and Drug Administration.
In a System 100 treatment study involving congestive heart failure patients with fluid overload, overall health benefits were substantial enough to improve patients' overall heart ranking on the New York Heart Association classification scale, a widely used measurement. Further, System 100 treatment reduced hospital stays by two days, when compared to patients receiving conventional diuretic treatment - a significant cost savings. Patients lost an average of five pounds (primarily water), reducing weight straining the heart and often increasing mobility.
Fluid Overload and Congestive Heart Failure
Patients with congestive heart failure represent the largest group of fluid-overload patients. Fluid overload can be caused by many things, including renal failure, post-surgical fluid overload, metabolic disease and congestive heart failure.
Congestive heart failure (CHF) is the progressive inability of the heart to pump enough blood to support the vital organs; deterioration of the heart muscle leads to decreased pumping capacity, elevated stress on the heart and increased fluid retention. In the United States each year, there are 3.1 million hospital admissions for congestive heart failure, at a cost of more than $23 billion.
An estimated 5 million people suffer from the condition in the United States. Congestive heart failure is the fastest-growing cardiovascular disease, with 550,000 diagnoses annually in the United States. The American Heart Association calls congestive heart failure "the disease of the millennium."
About the Minnesota Heart Failure Consortium
The health care professionals of the Minnesota Heart Failure Consortium (MHFC) are dedicated to furthering research and education concerning the problem of heart failure. MHFC facilitates cooperative educational and investigative efforts among individual medical groups and institutions involved with the care of patients with chronic heart failure. Current consortium members include: Abbott Northwestern, Hennepin County Medical Center, Mayo Clinic, Mercy Medical Center, Park Nicollet, Region's Hospital, St. Paul Heart, University of Minnesota and the VA Medical Center.
MHFC is a special program of the Minneapolis Medical Research Foundation (MMRF), which oversees research on the campus of Hennepin County Medical Center, a nationally recognized research and teaching hospital. The mission of the MMRF is to improve patient care and health of the community through research and education. MMRF is the third-largest non-profit medical research organization in Minnesota and ranks in the top 10 percent of institutions receiving research funding from the National Institutes of Health.
About CHF Solutions
CHF Solutions, based in Brooklyn Park, Minn., is a privately held manufacturer of innovative medical devices for cardiac care. The company's mission is to provide medical practitioners with innovative and proprietary solutions that enable the treatment of patients with unmet clinical needs. For additional information about the System 100 and CHF Solutions, visit Chf Solutions.
