FDA CLEARS FRESENIUS MACHINE FOR HOME DIALYSIS

[okarol]

FDA CLEARS FRESENIUS MACHINE FOR HOME DIALYSIS
35 minutes ago

Posted in News, Clinical & Pharma, Government & Regulation, Fresenius, Home Dialysis

WALTHAM, Mass.—The U.S. Food and Drug Administration (FDA) has cleared Fresenius Medical Care’s 2008K@home dialysis machine.

The machine is specifically designed to facilitate hemodialysis treatment in the home environment.

"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, according to Fresenius.

The 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.

http://www.renalbusiness.com/news/2011/02/fda-clears-fresenius-machine-for-home-dialysis.aspx

[MooseMom]

Does anyone know how this machine is different from the NxStage System One?

On a side note, I've been in contact with a lady in the medical devices division of the FDA; I've been asking her about this whole business of us needing FDA approval for nocturnal with NxStage.  She sent me a link to this story about this new machine despite the fact that today is a federal holiday!  I thought that was really nice and told her to please find something more fun to do on her day off than email me about home dialysis machines!

[greg10]

http://forums.homedialysis.org/showthread.php/1770-Little-K-machine

April 9, 2008 11:56 AM
 
Dori Schatell

The Baby K was on the market--approved by the FDA--for years. When the Aksys PHD machine was designed as a home-only machine, they had to jump through an additional hoop: a study of the machine in the home to be sure it was safe. So, that machine got a home dialysis approval.

Having one machine with a home dialysis approval raised the bar for other home HD machines. So, when the NxStage System One machine came on the market (for use in acute dialysis--and at home), they did a home study to get both regular approval and home approval. The Allient Sorbent machine by Renal Solutions is doing the same.

Probably Fresenius thought the Baby K was "grandfathered" in, because it had been on the market prior to the Aksys PHD. Apparently the FDA disagreed, so now they may jump through that hoop.  have no idea if they are looking at the Baby K for daily or nocturnal in particular--the issue is home.

[Desert Dancer]

The 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.

Hmm. I wonder what machine I've been using since November of last year?

[MooseMom]

NxStage and Fresenius square off in home dialysis market
February 22, 2011 by MassDevice staffRenal therapy giant Fresenius Medical Care Holdings Inc. looks to knock off NxStage Medical Inc. with the launch of the 2008K@home dialysis machine for patients with kidney failure.

Fresenius Medical Care Holdings Inc. (NYSE:FMS) is getting into the home dialysis game with the release of a more portable version of its in-center 2008-series hemodialysis machines for patients with acute kidney failure.

Fresenius, the world's largest dialysis maker said that it received Food & Drug Administration clearance for its 2008K@home dialysis machine and will have it on the market during the early summer, according to a prepared statement.

Fresenius' move into the home game puts the Waltham, Mass.-based company in direct competition with its neighbor 30 miles to the north, NxStage Medical Inc. (NSDQ:NXTM) , which makes portable dialysis machines.

Leerink Swann analyst Danielle Antalffy, who covers NxStage for the investment bank, called the move "clearly a negative headline" for the company in an email for investors. However, she pointed out that the 2008k @home was "large, not truly portable, and requires significant plumbing/electrical alterations in the patient's home."

"Because of this, our industry checks out of Annual Dialysis Conference (ADC) suggest that NXTM's System One maintains a significant competitive advantage given System One's small size, portability, and lack of cumbersome plumbing/electrical requirements," she wrote.

Furthermore, Fresenius could actually help raise awareness for NxStage, which posted a 21 percent increase in its top line during 2010, according to Antalffy.

Last week, the company said it narrowed losses in 2010 to $26 million on $179 million in sales, compared to a $36 million loss on $149 million in revenues during 2009. The bulk of the top line growth came from robust sales in its home dialysis machines, which jumped 35 percent during the year.

However, The Street doesn't seem to share Antalffy's confidence, as shares of NXTM fell more than 10 percent by the early afternoon to $20.25, down $2.33 from Friday's closing price of $22.58.

In other news, NxStage touted the results of an independent study that showed its home dialysis machines were more eco-friendly than their in-center counterparts. The report, published in the January issue of Hemodialysis International, said that the company's System One home dialysis machines had a 50 percent smaller carbon footprint when compared to traditional in-center hemodialysis machines.