CHF Solutions Launches Aquadex FlexFlow Fluid Removal System.BROOKLYN PARK, Minn. -- Next-Generation System Offers Greater Flexibility and Precision in Treating Fluid-Overloaded Patients CHF CHF In currencies, this is the abbreviation for the Swiss Franc. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 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 fluid overload Hypervolemia, plethora Medtalk A systemic excess of fluids. Cf Volume depletion. caused by many things, including renal failure renal failure n. Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema, , post-surgical fluid overload, metabolic disease metabolic disease, n a disorder that causes dysfunction of the metabolic action of the body, resulting in loss of control of homeostasis. paraneoplastic syndrome and congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. (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 Lung Transplantation Definition Lung transplantation involves removal of one or both diseased lungs from a patient and the replacement of the lungs with healthy organs from a donor. , 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 Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. . 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 Hennepin County Medical Center (HCMC) is a Level I trauma center based in Minneapolis, Minnesota, the county seat of Hennepin County. The primary 422-bed facility is located on five city blocks across the street from the Hubert H. , Minneapolis. The Aquadex FlexFlow will also be used in the ongoing UNLOAD clinical trial, a prospective, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. and controlled study that will enroll 200 patients at over 20 U.S. clinical sites. Called the UltrafiltratioN ultrafiltration /ul·tra·fil·tra·tion/ (ul?trah-fil-tra´shun) filtration through a filter capable of removing very minute (ultramicroscopic) particles. ul·tra·fil·tra·tion n. versus IV Diuretics Diuretics Definition Diuretics are medicines that help reduce the amount of water in the body. Purpose Diuretics are used to treat the buildup of excess fluid in the body that occurs with some medical conditions such as congestive heart 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. 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. The Aquadex FlexFlow system performs an advanced form of ultrafiltration, Aquapheresis, which can remove up to four liters (one gallon) of excess fluid from the body in eight hours. Unlike some drug-based therapies, Aquapheresis removes this fluid with no clinically significant impact on electrolytes, heart rate or blood pressure. The procedure is highly automated, easy to use, transportable and can be performed in virtually any clinical setting. For additional information about CHF Solutions, Aquapheresis, and the Aquadex FlexFlow, visit www.chfsolutions.com. |
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