CHF Solutions Launches Aquadex FlexFlow Fluid Removal System

CHF Solutions, Inc., a private medical device manufacturer, has launched the Aquadex(TM) FlexFlow(TM) System, the next-generation of its pioneering technology used to treat fluid overload caused by many things, including renal failure, post-surgical fluid overload, metabolic disease and congestive heart failure (CHF). The new system gives physicians greater flexibility and precision in setting blood-flow and fluid-removal rates. The company is introducing the Aquadex FlexFlow at the annual conference of the International Society for Heart and Lung Transplantation, April 5-9, in Philadelphia.

Fluid overload in patients can cause swollen legs and arms, fatigue, and eventually severe and life-threatening shortness of breath. The Aquadex FlexFlow is used to perform Aquapheresis(TM), a procedure to safely and predictably remove excess salt and water from fluid-overloaded patients. The Aquadex FlexFlow can be easily adjusted to meet individual patients' needs.

"As the name indicates, the Aquadex FlexFlow offers physicians greater flexibility and expands the number of fluid-overloaded patients who can receive Aquapheresis treatment," said John Erb, chief executive officer of CHF Solutions. "We know that individual patients respond differently to Aquapheresis therapy. With the Aquadex FlexFlow system, physicians can increase or decrease the rate of blood flow and fluid removal, enhancing the efficiency of this treatment. The new system reflects our commitment to providing innovative, practical solutions to address patient needs."

CHF Solutions received 510(k) marketing clearance for the Aquadex FlexFlow System from the U.S. Food and Drug Administration in 2004. With the new system, physicians have more choices in venous access sites and expanded catheter capability.

"The possibilities for applications on fluid-overloaded patients are now greatly expanded, and I am really excited about the future," said Dr. Bradley Bart, a cardiologist at the Hennepin Heart Center and director of Nuclear Cardiac Imaging at Hennepin County Medical Center, Minneapolis.

The Aquadex FlexFlow will also be used in the ongoing UNLOAD clinical trial, a prospective, randomized and controlled study that will enroll 200 patients at over 20 U.S. clinical sites. Called the UltrafiltratioN versus IV Diuretics for Patients HospitaLized for Acute Decompensated Congestive Heart Failure (UNLOAD), this trial will compare the long-term safety and efficacy of treatment with the Aquadex FlexFlow System technology to conventional pharmaceutical therapy. CHF Solutions expects to announce clinical trial results in the fourth quarter of 2005. Previous clinical studies evaluating Aquapheresis therapy are all pertinent to the Aquadex FlexFlow System.

Fluid Overload and Congestive Heart Failure

Fluid overload can cause severe fatigue, shortness of breath and subsequent hospitalizations and can be caused by many conditions including renal failure, post-surgical fluid overload, metabolic disease and congestive heart failure. Patients with congestive heart failure represent the largest group of fluid-overloaded patients. An estimated five million Americans suffer from the condition, incurring 3.1 million hospital admissions at a cost of more than $23 billion annually. With the aging population, congestive heart failure diagnoses are growing eight percent annually in the United States.