LIXELLE question for Peckham and HEMODOC

[noahvale]

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[Bill Peckham]

Are you familiar with this product for increasing B2 microglobulin removal during dialysis?  Is cost the only reason clinics in the U.S. are not including Lixelle?  Since amyloidosis is a major complication of long term dialysis, it only makes sense to utilize this product. 

I remember when on dialysis in the mid-1980s, a charcoal filter was periodically attached during treatment to remove aluminum buildup from the most effective phosphorus binder prescribed at the time.  Medicare and insurance paid for that, but then again, it was before bundling.

http://www.ncbi.nlm.nih.gov/pubmed/12921124
http://www.ncbi.nlm.nih.gov/pubmed/15084199

You might interested in this PDF http://jasn.asnjournals.org/content/early/2009/01/07/ASN.2008080899.full.pdf


Sorbent columns generally are having trouble pricing out - the FMC Allient system has been 6 months from launch for four years - in the current post bundle environment  The bundle makes the sorbent systems marginally more economically viable but its a low bar. Prebundle they were even farther from profitability.


If CMS saw use of a column like Lixelle as a separate procedure, above and beyond a hemodialysis treatment, that would get it into use but if it has to be funded out of the bundle the money isn't there - if I as I assume these would cost about $70 - $80/treatment.

[noahvale]

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[Hemodoc]

Are you familiar with this product for increasing B2 microglobulin removal during dialysis?  Is cost the only reason clinics in the U.S. are not including Lixelle?  Since amyloidosis is a major complication of long term dialysis, it only makes sense to utilize this product. 

I remember when on dialysis in the mid-1980s, a charcoal filter was periodically attached during treatment to remove aluminum buildup from the most effective phosphorus binder prescribed at the time.  Medicare and insurance paid for that, but then again, it was before bundling.

http://www.ncbi.nlm.nih.gov/pubmed/12921124
http://www.ncbi.nlm.nih.gov/pubmed/15084199

You might interested in this PDF http://jasn.asnjournals.org/content/early/2009/01/07/ASN.2008080899.full.pdf


Sorbent columns generally are having trouble pricing out - the FMC Allient system has been 6 months from launch for four years - in the current post bundle environment  The bundle makes the sorbent systems marginally more economically viable but its a low bar. Prebundle they were even farther from profitability.


If CMS saw use of a column like Lixelle as a separate procedure, above and beyond a hemodialysis treatment, that would get it into use but if it has to be funded out of the bundle the money isn't there - if I as I assume these would cost about $70 - $80/treatment.

Rerun forwarded this thread to me to comment. Actually, I can't comment in any depth since I have signed a 5 year non-disclosure agreement with FMC for the privilege of viewing their sorbent system last January. I wrote a post on the Allient system on Hemodoc that the CEO took issue with personally. He invited me to their research facilities to speak with the lead inventors and developers of their version of the sorbent system. It was a very interesting event and I was able to spend three hours with Ben Lipps, the CEO and the head of their program without interruption.

http://www.hemodoc.com/2012/01/has-anyone-seen-the-new-sorbent-machines-can-you-tell-me-where-they-have-gone.html

I can state what Dr. John Agar has stated who is a medical advisor for this program, it is a very intriguing technological paradigm that would in many ways revolutionize dialysis treatments at home and even in-center. It is waiting final FDA approval. You can look at what Dr. Agar has on his website pending this approval which many of us hope is soon.

http://www.nocturnaldialysis.org/technology_whats_coming.htm

[Rerun]

So you have a GAG order?

Interesting.      Okay, you have 4 years left and then you have to tell us everything.     

[Zach]

Are you familiar with this product for increasing B2 microglobulin removal during dialysis?  Is cost the only reason clinics in the U.S. are not including Lixelle?  Since amyloidosis is a major complication of long term dialysis, it only makes sense to utilize this product. 

I remember when on dialysis in the mid-1980s, a charcoal filter was periodically attached during treatment to remove aluminum buildup from the most effective phosphorus binder prescribed at the time.  Medicare and insurance paid for that, but then again, it was before bundling.

http://www.ncbi.nlm.nih.gov/pubmed/12921124
http://www.ncbi.nlm.nih.gov/pubmed/15084199

Is this product still available in the U.S.?

[Hemodoc]

So you have a GAG order?

Interesting.      Okay, you have 4 years left and then you have to tell us everything.     

Actually, NxStage invited me to speak at the ADC last year at a private gathering and wanted me to sign a Nondisclosure agreement that would have taken away all of my rights to comment on just about anything dialysis. All that for no pay at all. I declined.

The FMC NDA is quite generous really. Anything on their products I can find online are not covered and as soon as it comes to market, the NDA ends as well. The PAK was only one of the items on the NDA, there is much more to come as you CAN see on public records on the internet.

http://www.fmc-ag.com/files/110920_SCB_Strategic_Decisions_Conf_Ldn.pdf

Go to page 12 and you will see the outline of how their new technology related to the 2011 business strategy. You see the PAK and the "assisted dialysis just like home which is a new model" of care developed around the PAK. Take a look under PD and you will see "Wearable Kidney." Can't talk about anything else at all, but even though is is public access knowledge, you don't hear anyone speaking of this but it is on the internet. Sorry, wish I could say more, but some really neat stuff coming folks and that is just one company. There are dozens of new devices in development at the present time, some closer to production than others.

I can state that FMC is not the least bit worried about the alleged production costs of their sorbent technology. I asked them directly about that issue.  Can't state what they said, but they know business and that is not a concern whatsoever. That is about all I can state about my brief glimpse on the inside of their new developments. Neat stuff coming and hope it gets here soon is all I can say. Dr. Agar has the most detailed info on the general aspects of the new dialysis machines, but don't forget that we have a AWAK PD device by UCLA, a AWAK Hemo device by Victor Gura who now has approval for US trials on patients through Seattle's NKC research related unit that Bill is involved with.

Victor sent me some info a couple of weeks ago that I need to update a post. Lot's of stuff in the pipeline which is our only hope for changing the dialysis paradigm in America. Hopefully, we will see something soon. Bill had a similar review of the BEKA system a few years back and that may be ready to come online soon as well. Competition will be good for the US dialysis market, it is our best hope.

[noahvale]

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[Zach]

Is this product still available in the U.S.?

I don't know and in their responses, Bill and Peter, didn't offer up that info.  I'm seeing my former dialysis nephrologist on Tuesday and hopefully he will give me more info plus maybe a way to get Medicare to cover it outside the bundle.  Do you have experience with Lixelle?

No personal experience.
But those of us on hemodialysis for many years need a way to deal with amyloid issues.

[Bill Peckham]

Some info about amyloid:http://homedialysis.org/article/life_at_home/avoiding_a_pain_in_the_neck_dialysis_related_amyloidosis


I doubt Lixelle is available in the US because they were not an exhibitor at KidneyWeek - the annual American Society of Nephrology conference.


I think you would get some good information if you asked Dr Agar what he knows about it:
http://forums.homedialysis.org/forums/16-Dr-John-Agar-Nephrologist

[Zach]

Some info about amyloid:http://homedialysis.org/article/life_at_home/avoiding_a_pain_in_the_neck_dialysis_related_amyloidosis


I doubt Lixelle is available in the US because they were not an exhibitor at KidneyWeek - the annual American Society of Nephrology conference.


I think you would get some good information if you asked Dr Agar what he knows about it:
http://forums.homedialysis.org/forums/16-Dr-John-Agar-Nephrologist

Thanks Bill.

[lmunchkin]

Hey Peter, how is the new PAK any different than what's in the PureFlow System? Or are you allowed to answer?  Maybe its a different PAK.  Ours is a heavy "Card" that slides in the side of PF system cabinet.  It contains 5to6 filters, kind a like a mini water treatment center.  The water passes through each filter till the end, where it is tested before use of batch.

Jesus is Lord,
lmunchkin

[Hemodoc]

Hey Peter, how is the new PAK any different than what's in the PureFlow System? Or are you allowed to answer?  Maybe its a different PAK.  Ours is a heavy "Card" that slides in the side of PF system cabinet.  It contains 5to6 filters, kind a like a mini water treatment center.  The water passes through each filter till the end, where it is tested before use of batch.

Jesus is Lord,
lmunchkin

Dear lmunchkin

The FMC research lab, RSI, has a great discussion on sorbent technology that the PAK uses. It is the same system as on their website. The PAK incorporates elements from the Xcorporeal XCR-6 and improved it. That was Victor Gura's company that FMC bought when they were in financial trouble.  Victor is still developing the AWAK in Seattle with the research group Bill is associated with.

The Sorbent system is currently completely trials with the FMC 2008 Sorbent system in NY state to test the sorbent side of the PAK.

http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093362.pdf

So, lot's of information on sorbent online that is open to discussion.

http://www.renalsolutionsinc.com/

[Zach]

Any news about Lixelle?

 

[Rerun]

Good memory.

                

[Dman73]

Lixelle has been used in Japan for years but they are leading edge in D compared to our system and their mortality rates are lower than ours.

http://www.kaneka-med.jp/english/products/apheresis/px_001a/

I don't know if/when we will be using such a system but as a 40 yrs D patient I do have amyloid problems. I have carpal tunnel in both hands and have gone through the surgery route where now the surgeon's say that they can't help me any more.

http://www.homedialysis.org/life-at-home/articles/dialysis-related-amyloidosis

I am currently using the equivalent of 6-10 cups per day of green tea via supplement trying to reduce inflammation and dissolve amyloid and will be adding turmeric to help achieve that goal.

[amanda100wilson]

Dman73 where do you get the green tea supplements from?  I am having carpal tunnel surgery on Friday and suffer with pain in and around tendons in my legs.

[Zach]

I am currently using the equivalent of 6-10 cups per day of green tea via supplement trying to reduce inflammation and dissolve amyloid and will be adding turmeric to help achieve that goal.

What are your CRP and β2 microglobulin blood levels?

 

[Dman73]

Dman73 where do you get the green tea supplements from?

Amanda.. I get my green tea supplements from the following website and are much cheaper than buying locally.
 
http://www.swansonvitamins.com/natures-way-standardized-green-tea-extract-30-caps

What are your CRP and β2 microglobulin blood levels?

Zach... I have never been tested for CRP and β2 microglobulin levels.  The last time I had carpal tunnel surgery my nephrologist asked asked the surgeon to send some tissue biopsy to be tested but she forgot.
I know I have amyloid because of my time on D, history of carpal tunnel and rupturing finger, arm & leg muscles.

[Zach]

I am currently using the equivalent of 6-10 cups per day of green tea via supplement trying to reduce inflammation and dissolve amyloid and will be adding turmeric to help achieve that goal.

Is there not a risk of Hepatotoxicity with the use of some green tea supplements?

[Dman73]

Is there not a risk of Hepatotoxicity with the use of some green tea supplements?

Zack... I use a standardized green tea (Natures Way from Swansons) that 2 pills contain the same amount of EGCG as 3 cups of brewed tea. I used to take 6 pills per day or the equivalent of 9 cups of green tea for three years with no evidence of liver damage in my monthly lab reports. I currently take 4 pills per day or the equivalent of 6 cups of green tea.

I have read where there is a possibility of Hepatotoxicity when taking high doses > 24 cups per day and that is why I take less that half of that dosage.
I started with 2 pills and gradually worked my way to 6 with no ill effects but Natures Way does have a disclaimer to not use while nursing.

There are too many good benefits of taking some green tea than to avoid it altogether.
In any case it would be best to consult your Nephrologist and/or Dietitian.   

[Zach]

Good News!

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436864.htm

FDA News Release

FDA authorizes use of first device to treat patients with dialysis-related amyloidosis
For Immediate Release

March 6, 2015
Release

The U.S. Food and Drug Administration today authorized use of Lixelle Beta 2-microglobulin Apheresis Column, the first device to treat dialysis-related amyloidosis (DRA).

Dialysis-related amyloidosis is a chronic, progressive condition caused by the buildup in the body of a protein called beta 2-microglobulin. Dialysis-related amyloidosis is a complication of kidney failure. As beta 2-microglobulin builds up in the blood, deposits of the protein can form in the bones, joints and tendons causing painful and stiff joints, bone cysts that can lead to bone fractures, and torn tendons and ligaments. Beta 2-microglobulin deposits can also affect the digestive tract and organs, such as the heart and lungs.

Dialysis-related amyloidosis most often occurs in patients with kidney failure, especially adults older than 60, who have been on hemodialysis for more than five years.   

The Lixelle Column works by removing beta 2-microglobin from the blood. It contains porous cellulose beads specifically designed to bind to beta 2-microglobulin as the patient’s blood passes over the beads. The device is used in conjunction with hemodialysis, a treatment where blood circulates outside the body through a special filter that removes waste products and extra fluid. The clean blood is returned to the body. When the Lixelle Column is used, the blood passes through the Lixelle Column before it enters the dialysis filter.

The device may help patients who have developed symptoms related to DRA and may be especially useful for those patients who may not have access to extended dialysis therapies or who may not be eligible for a kidney transplant.

“While DRA affects only a small population of patients on dialysis, there are not many treatment options for these patients and some options may not be available to patients in all areas,” said William Maisel, M.D., M.P.H., deputy director for science, chief scientist and acting director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health. “The Lixelle Beta 2-microglobulin Apheresis Column may provide this patient population with an option for relieving some of the debilitating symptoms of DRA.” 

The FDA reviewed the Lixelle Column through the Humanitarian Device Exemption (HDE) pathway after granting it a Humanitarian Use Device (HUD) designation. An HDE is an application that is similar to a premarket approval application (PMA), but it is exempt from the effectiveness requirements that apply to PMAs. Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the U.S. per year. In order to receive HDE approval for a HUD, a company must demonstrate safety and probable benefit of the device (i.e., that the device will not expose patients to an unreasonable or significant risk of illness or injury, and that the probable benefit of the device outweighs the risk of injury or illness from its use), and that there are no legally-marketed comparable devices, other than a device approved under the HDE or investigational device exemption (IDE), available to treat or diagnose the disease or condition.

Data supporting the safety and probable benefit of the Lixelle Column include published clinical studies describing treatment of approximately 100 patients from Japan with DRA, and postmarket safety data from approximately 200 patients in Japan where the device has been approved for use. The studies generally showed improvement in symptoms associated with DRA with use of the device.

The most common adverse events associated with the device’s use are temporary hypotension (low blood pressure) and a decrease in red blood cell count (hematocrit). These are common adverse events for patients undergoing dialysis or any extracorporeal therapy (treatment that takes place outside of the body). As a condition of the HDE approval, the company must conduct a postmarket study to gain more data on the benefits, risks, and adverse events in the U.S. population.

The Lixelle Column is manufactured by Kaneka Corporation in Osaka, Japan and distributed in the U.S. by its subsidiary, Kaneka Pharma America.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

[noahvale]

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[Zach]

Hi noahvale,

I think there will be some testing of the column first and probably a set of criteria will be developed as to who on hemodialysis may qualify. As you said, perhaps a ton of red tape.

In Japan, one study used the following criteria:
 (i) b2M-based amyloid deposition revealed by Congo red staining and immunostaining of tissue samples obtained from lesions at surgery for carpal tunnel syndrome or on biopsy; (ii) dialysis for >10 years and carpal tunnel release; and (iii) the presence of bone cysts in their joints, confirmed by X-ray imaging.

Regional renal research hospitals might be the first to use the columns on their patients, so Atlanta and New York are sure to be among those.

Let's hope for a speedy on-ramp for this proven technology!

Regards,
--Zach
 

PS:  From what I've read, interestingly enough, many on hemodialysis in Japan are using low-flux dialyzers to "preserve" their nutritional status.
      That plus the column to keep their B₂M in check.  Would you be willing to change to a low-flux dialyzer (Fresenius F-8) if you could use the Lixelle?

[noahvale]

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