Devices Cardiology

 News Release - February 6, 2007

Study Showing Benefits of Ultrafiltration Therapy for Heart Failure Patients Published in Journal of American College of Cardiology

Landmark UNLOAD Study Demonstrates That Aquapheresis(TM) Results in Greater Weight and Fluid Loss, and Reduced Rehospitalizations in Heart Failure Patients with Fluid Overload

MINNEAPOLIS--(HSMN NewsFeed)--Results of a clinical study published in the February 13, 2007, edition of the Journal of American College of Cardiology (JACC), show that hospitalized heart failure patients receiving a unique and simplified form of ultrafiltration therapy (Aquapheresis(TM)) as part of their care lost more weight, experienced greater net fluid loss, and had fewer rehospitalizations than patients treated primarily with intravenous diuretics. The UNLOAD clinical trial is the first randomized study to compare the safety and efficacy of a non-drug-based option with standard intravenous diuretic drug therapy to treat heart failure patients. Heart failure, a progressive and debilitating disease, costs the U.S. healthcare system an estimated $29 billion annually.

"In the U.S., 90 percent of the 1 million annual hospitalizations for heart failure are due to fluid overload. Current treatment strategies which rely solely on intravenous diuretics have limited efficacy, as indicated by the re-hospitalization rates for worsening heart failure," said UNLOAD Study Principal Investigator Maria Rosa Costanzo, M.D., Midwest Heart Specialists, Chicago. "The results of the UNLOAD trial clearly indicate that mechanical fluid removal with Aquapheresis is a safe and effective therapy in patients with decompensated heart failure. Aquapheresis not only removed more fluid than intravenous diuretics, but it was also associated with an impressive reduction in re-hospitalizations for worsening heart failure. The patients enrolled in UNLOAD are very representative of the typical decompensated heart failure population. Therefore, we believe that the results of UNLOAD represent an important development in treating fluid overload and are immediately applicable to a large portion of patients who are admitted to the hospital with decompensated heart failure." Dr. Costanzo will present further analysis of the UNLOAD data at the March 24-27, 2007 American College of Cardiology (ACC) 56th Scientific Session in New Orleans.

In the UNLOAD study, 200 patients with acute decompensated heart failure were equally randomized at 28 institutions across the United States to either ultrafiltration using the Aquadex FlexFlow(TM) system or standard IV (intravenous) diuretic therapy, and evaluated at 48 hours and out to 90 days following discharge. The Aquadex FlexFlow, a system developed and manufactured by CHF Solutions, delivers the Aquapheresis therapy. At 48 hours into treatment, the ultrafiltration group demonstrated a:

• 38 percent greater weight loss over standard care;
• 28 percent greater net fluid loss over standard care; and
• Improvement in dyspnea score (breathing).

At 90 days after discharge, the ultrafiltration group had a:

• 43 percent decline in patients requiring rehospitalizations for heart failure;
• 50 percent reduction in total number of rehospitalizations for heart failure;
• 63 percent total decrease in days rehospitalized for heart failure; and
• 52 percent reduction in emergency department or clinic visits.

"The UNLOAD study results conclusively demonstrate that physicians, nurses and hospitals have a safe, more predictable, more effective and simply a better way to manage CHF patients with fluid overload," said David Springer, president and chief executive officer of CHF Solutions, the trial sponsor. "Aquapheresis can remove over six times more water and 12 times more salt in a 24-hour period compared to standard care using diuretic drugs. This can translate into immediate and long-term clinical and economic benefits to patients and the healthcare system."

For more information about the UNLOAD study and its results, go to www.unloadstudy.com .

About Fluid Overload and Heart Failure

Fluid overload can be caused by many things, including problems with the heart, kidneys, lungs or any combination of these vital organs. The leading cause of fluid overload is congestive heart failure (CHF), sometimes referred to as heart failure (HF). Heart failure is the progressive inability of the heart to pump enough blood to support the vital organs and often leads to a build up of fluid, causing swollen legs and arms, fatigue and eventually excess fluid in the lungs and severe life-threatening shortness of breath. Due to prolonged hospitalizations and high readmission rates, many hospitals often lose more than $1,000 for each heart failure patient admitted.

About Aquapheresis, the Aquadex FlexFlow and CHF Solutions

Ultrafiltration therapy with CHF Solutions' unique Aquadex FlexFlow system allows healthcare professionals to remove the excess salt and water in patients with fluid overload where, when and how they want. Inpatient or outpatient, peripheral or central venous access, its low blood flow, low extracorporeal blood volume, and precise removal rates enable safe, predictable and effective fluid removal.

CHF Solutions, based in Brooklyn Park, Minn., is a privately held manufacturer of medical devices for cardiac care. For more information, go to www.chfsolutions.com .

Source: CHF Solutions

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.