Fresenius Medical Care Receives FDA Clearance for 2008K@home™ Dialysis Machine

(BUSINESS WIRE)--Fresenius Medical Care (NYSE: FMS), the world’s leading company devoted to patient-oriented renal therapy, announced today that the U.S. Food and Drug Administration (FDA) cleared its 2008K@home™ dialysis machine. Specifically designed to facilitate hemodialysis treatment in the home environment, the newly approved device offers many patients more options for achieving adequate dialysis in the comfort of their own home.

"The 2008K@home offers the broadest range of dialysis prescription delivery, regardless of patient size or metabolic needs,” said Chief Medical and Regulatory Affairs Officer Jose Diaz-Buxo, MD, FACP. “It offers versatility and the reliability of many years of experience with this platform." The 2008K@home combines the known safety, efficacy and reliability of the 2008® series hemodialysis machines with a simpler user interface and additional new features specifically designed to facilitate home hemodialysis. 2008K@home incorporates all standard performance and safety features expected in modern hemodialysis machines.

The 2008K@home will be available to patients in the late spring/early summer, 2011. For more information call 800-662-1237 ext. 2053.

2008K@home and 2008 are trademarks of Fresenius Medical Care. 

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Rep. Lewis Commends Kidney Care Partners' Health Care Campaign to Improve Survival Rates of First-Year Dialysis Patients in Georgia

/PRNewswire / -- Kidney Care Partners announced the launch of a voluntary quality improvement campaign pledging to reduce mortality among first-year dialysis patients - those at the greatest risk - in Georgia and across the country by 20 percent by the end of 2012.

The "Performance Excellence and Accountability in Kidney Care" or PEAK Campaign (www.kidneycarequality.org) to reduce mortality in the first year will focus on patient education and key clinical care activities to achieve its goal.

Led by Kidney Care Partners, with support from research partners at Brown University and Quality Partners of Rhode Island as well as experts in the kidney community, the PEAK Campaign will:

-- Equip health care providers with tools to help first-year dialysis
patients better transition;
-- Improve the health and survival of first-year dialysis patients;
-- Result in reduced hospitalizations, thus resulting in Medicare
savings.


The PEAK campaign has garnered support not only from a broad cross-section of the kidney community but also from policymakers. "This Congress is deeply committed to resolving the fundamental challenges of health care delivery in this country, but we cannot do it alone," said Rep. John Lewis (D-GA), sponsor of the Kidney Care Quality and Education Act of 2007, which included patient-centered education programs and linked reimbursement with quality care - provisions which were ultimately passed as part of the Medicare legislation of 2008. "We need organizations like KCP to target specific problem areas in the community and find ways to respond. Saving lives is the goal that motivates us all."

Kidney disease affects more than 26 million people nationwide. Approximately 400,000 Americans suffer from kidney failure and require dialysis or kidney transplantation to survive. Transplants are limited due to the shortage of donor organs, so most patients undergo dialysis for three to four hours, three times a week. The number of Americans with kidney disease is rising steadily due to risk factors including diabetes, hypertension, obesity and high blood pressure.

African Americans, Hispanics and other minority groups are most at-risk for developing kidney failure. And while African Americans make up just 12 percent of the general population, they account for 30 percent of people with kidney failure.

There were 3,790 new dialysis patients in 2007 in Georgia alone, a 15 percent increase since 2003, and a total of 14,086 patients on dialysis in 2007 in Georgia, a more than 20 percent increase since 2003, according to the Southeastern Kidney Council.

All too often, the onset of chronic kidney disease (CKD) is gradual and undetected, leaving patients especially vulnerable when the disease is recognized. Helping patients to understand their disease and to manage it appropriately is an essential ingredient to high quality care for newly diagnosed patients and a central component of the PEAK Campaign.

"The kidney care community has achieved considerable and measurable quality improvements in the last decade. The goal of the PEAK Campaign is to help us achieve comparable results in the next decade," said Kent Thiry, KCP Chair. "Our Campaign focuses on patients who are new to dialysis, because these patients are particularly vulnerable. One challenge is to help these patients understand and effectively manage their disease. We also will start a systematic community-wide process of identifying and sharing 'breakthrough' practices that will improve survival rates."

While the survival rate of end-stage renal disease (ESRD) patients has improved, mortality in the first year of dialysis has remained stable during the last decade. The kidney care community has recognized the need to improve the first-year mortality rate as compared to other industrialized nations.

With recommendations from our research partners, KCP will encourage providers to further improve outcomes for first-year dialysis patients in an effort to extend, even save, 10,000 lives.

"Dialysis providers already have robust quality improvement programs in place to ensure consistent delivery of high quality care. The kidney care community looks forward to undertaking this voluntary effort to take quality improvement to the next level," KCP's Thiry added.

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