FDA Approves Home Dialysis Machine From Fresenius Medical Care

February 21, 2011
103 Views

If maintained properly the machine could offer some real convenience of not having to go to a facility for treatment.  I would almost guess that someone would need to make an in-house visit from time to time to check the unit out and make sure it’s working properly.  If I am reading this correctly, it can work while the patient sleeps and that sounds like a real plus as far as time.  The unit could also be used at a hospital.  The unit also comes with software “PatientOnLine” which offers monitoring by clinical

If maintained properly the machine could offer some real convenience of not having to go to a facility for treatment.  I would almost guess that someone would need to make an in-house visit from time to time to check the unit out and make sure it’s working properly.  If I am reading this correctly, it can work while the patient sleeps and that sounds like a real plus as far as time.  The unit could also be used at a hospital.  The unit also comes with software “PatientOnLine” which offers monitoring by clinical professionals as well.  BD 

Press Release:

WALTHAM, Mass.–(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”

“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.

About Fresenius Medical Care

Fresenius Medical Care (NYSE: FMS) is the world’s leading company devoted to patient-oriented renal therapy. Through more than 2,700 clinics in North America, Europe, Latin America, Asia-Pacific and Africa, we provide kidney dialysis treatments to approximately 210,000 patients worldwide. We are also the world’s leading maker of dialysis products such as hemodialysis machines, dialyzers and related disposable products. Chronic kidney failure is a condition that affects about 1.9 million individuals worldwide. For more information about the company’s more than 1,800 U.S. dialysis facilities, visit www.ultracare-dialysis.com(in English and Spanish). For more information about Fresenius Medical Care, visit www.fmc-ag.com or www.fmcna.com

Disclaimer

This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA’s reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.

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

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