An Obituary for Baxter’s Vivia Home HD Machine

This blog post was made by Dr. John Agar on September 8th, 2016.
An Obituary for Baxter’s Vivia Home HD Machine

(Vivia…from vivere: to live)

A month or two ago, I listened with more than a tinge of sadness as the new CEO at Baxter Healthcare in Illinois announced and sought to explain withdrawal of the Vivia.

Was it from this announcement, or from elsewhere, I truly don't quite recall, that I gained a sense—a feeling—that Baxter no longer had full confidence in the home market?

Could that be true? Surely not!  But, implicit in the withdrawal of the Vivia had to be one of two truisms: 

1. Baxter correctly read the home haemodialysis market and come to the devastating conclusion that it was losing viability

or...

2. The Vivia withdrawal was a simple but tacit admission that the Baxter Vivia was, in effect: the wrong design, wrong stability, wrong machine…and wrong time! 

To be honest, we may never know. Suffice it to say: another hope-for-the-side has bitten the dust. And, that is sad. The Vivia had stuff going for it. It was to be the golden child of a global corporate colossus; the reinvention of a wild child of the 90's: the AKSYS PHD machine. This was a revolutionary system I personally fell instantly in love with. Not as a design—it was ugly—but as a concept

I had met the AKSYS back in Charlotte NC at the ADC in 1997, the same conference where I found myself captivated and uplifted by a quietly spoken, humble man from Toronto who spoke about longer, slower, and frequent overnight dialysis: Andreas Pierratos. 

Both captured my imagination, man and machine.

Then, in the blink of an eye, nearly a decade passed; a decade during which I introduced the Pierratos model of frequent, gentle nocturnal dialysis to the long-established home dialysis ethos as practiced in ANZ, and a decade that saw the AKSYS struggle to a sad demise until it was ultimately shelved in New Hampshire. And, that was also sad.

The AKSYS had broken new ground: revolutionary technology, hot water sterilisation, fully reusable consumables, and simplicity of function. If only it had had the capital behind it to weather the inevitable technical teething problems and the fierce, even cut-throat competition waged by established competitors: the stormy seas faced by most new start-ups.

How thrilling it was to later learn that the AKSYS patents had been assumed by a global giant and that it might be refashioned into a viable home system!

But, there were predictable challenges inherent in the AKSYS designs. How might these designs impact a new commercial product later named the Vivia, as opposed to a designer’s dream?

The central feature was to be, like the AKSYS, reusable consumable: one set of lines, one dialyser, repeated hot water sterilisation between treatment after treatment; each consumable set designed (and, to make it viable, costed) to provide between 3-5 treatments/week for a full month of 30 days and potentially 15-20 treatments.  It was a delicious concept: a plug and go option, a once-a-month set up and pull down, a 5 minutes on and off users “joy,” if dialysis could ever be called a joy.

But, although the Vivia was intended to achieve a month’s worth of dialysis from each consumable set, the actual trials ran into real trouble, each consumable batch achieving much, much less.  I believe this proved hard to fix. And, from a commercial aspect, fewer—many fewer—runs per consumable set would:

  1. Increase patient set up time
  2. Increase frustration
  3. Reduce certainty and system “trust”
  4. Push consumable costs out of all proportion and certainly beyond any reasonable affordability.

And, as the Vivia (like the AKSYS before it) was, by definition, absolutely and utterly restricted to one patient per set of consumables, there was no possible option for its use OTHER THAN for in a one patient, in one home setting.

This absolute one-patient limitation held Vivia apart from all other systems. All other systems use a fresh set of lines and a fresh dialyser (or, in US reuse programs, a reprocessed one) for each dialysis. As such, all other systems can be multi-patient systems. Not so the Vivia. 

If desired, all other systems are designed for and can be used seamlessly across a multi-site, multi-platform dialysis landscape. All are suited as (and have been used to varying degrees) as ICU, in-centre, satellite, or home systems...wherever! Not so the Vivia. 

Further, while home patients have been vocal in seeking ever smaller and more portable systems to permit the flexibility of travel, Baxter turned round and made an immovable behemoth! No portability there! Conceptually a design delight, yes, but a big machine nonetheless. Indeed, even servicing and transport would have contravened Occupational Health and Safety (OH&S) regulations for single technicians. If not in the US, they certainly would have fallen foul of OH&S limits here in ANZ, where (1) home dialysis is far more prevalent in comparison to all other regions, and (2) OH&S rules are strict. 

So, was the Vivia withdrawn because Baxter had assessed that, in the near future, home dialysis may not prove a viable, vibrant, demanding, and profitable marketplace to enter?

Or, was the Vivia threatened by, and ultimately judged to be:

  • Big, when people want small
  • Fixed, when people craved portability
  • Uni-platform, when successful systems are multi-platform
  • Unreliable, when reliability is life and unreliability is death
  • Blood exposure-limited to one person only per one (expensive) consumable set

Was it the final assessment that, in the current environment, Vivia would never “fly”? Personally, I think this is likely so. And, perhaps the new Baxter CEO saw this early on, and pulled the pin, though we may never know for certain. Such is the way of commercial ventures.

But, if the Vivia was withdrawn because Baxter saw little or no future in home HD therapies (and I cannot believe that to be so) well, that viewpoint needs to be corrected somewhere, by someone, and quickly!

I say this because I, for one, believe passionately in the future of home dialysis. I believe home systems will be the way of the future for more, and not less, patients who depend on dialysis. Though machines and systems may variously come and go, home haemodialysis is irrefutably here to stay.

Comments

  • Peter Laird, MD

    Sep 18, 11:06 PM

    John and Mel, as a user of the NxStage for over 5 years and now on the Baby K, the difference in clearances beteween these two systems is night and day. While I miss the ease of set up and priming and the minimal cleaning requirements, I don't miss the high sodium of 140 and the low dialysate volumes.

    There have been serious quality issues with NxStage and their lactate system with aluminum contamination that for some patients is an ongoing issue. For these three reasons I switched to the Baby K.

    While I do feel much better with 160 liters of dialysate vs 40 liters, the work of setting up, cleaning up and mainting the Baby K is likely prohibitive for most patients.

    Since switching and using 136 sodium setting instead of 140, I have had almost a complete absence of constipation which was an issue on NxStage for me. I continue to believe many of the "usual" complications of dialysis are instead iatrogenic in nature and often preventable entirely with a different philosphy of dialysis, long and slow.

    I am saddened that what appeared to be another player in the home hemodialysis field has left NxStage as the sole provider for the majority of patients on home hemo in the US. The growing pains of this company has resulted in significant quality issues and after nearly 10 years of dialysis, it is stiffling to note that personally, I view only one viable option for myself, the Baby K.

    The home hemodialysis market is nearly devoid of any innovations viable today in all that time which is a remarkable statement when you view the rest of "modern" medicine improvements in the last 10 years. We are stagnating and the loss of the PAK if that is what is happening is an even more egregious loss since that promised high flow dialysate (500 ml/min) and portability.

    Will NxStage see any need whatsoever to upgrade and provide improvements without market place competition? That remains to be seen but it would not surprise me in the least that if I am fortunate to survive another10 years of this disease to still be using the Fresenius Baby K. That would be a very sad commentary on an even sadder industry.

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    • John Agar

      Sep 19, 10:10 PM

      You have said it all.

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  • Nieltje

    Sep 13, 11:26 AM

    I'm with you Henry! I can't believe the technology isn't there already. We as patients MUST continue to demand the r and d to get there and not let the LDOs control our destiny.

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  • Amanda Wilson

    Sep 10, 11:28 AM

    Dori, I wondered what had happened to that too. I also wonder if the Quanta will ever make it to the US, although I have never been sure if that is a truly portable machine even though they advertise it as such. Now what I would really like to see is the implantable kidney to be a success.

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    • John Agar

      Sep 13, 7:42 AM

      Amanda ..

      As a member of the Medical Advisory Board of Quanta, it is a nice system - despite that it needs an RO for providing its water - though being water in unlimited supply, appropriate blood to dialysate countercurrent flow rates permit better and more conventional clearance.

      But, water technology is also developing in some interesting and novel ways ... so, it is still a watch-this-space area.

      As for leaving the UK for wider distribution ... it takes any company with a complex product a long time to get out and about - remember that NxStage was up and about in the US for the best part of a decade before IT ventured off shore ex-US ... so, it is likely you will have to hang in there a while longer yet.

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  • John Agar

    Sep 8, 6:21 PM

    Mel ...

    I am so glad you are 'out there' to keep my perspectives on track. Yes ... of course you are right ... I have always lacked for any corporate/business synapses in my thinking and your 'take' on this demise is a refreshing additive.

    Indeed, I suspect that the truth shares elements of both of our perspectives. In what proportion? ... well, we'll never know.

    As for your views on the (current) lone survivor in your US HHD market - I share them. But, it now seems all you have over there to work with, unless or until another small transportable comes along. Let's hope that if/when one does, it ensures that dialysis performance is front and centre, and that it offers more than the current low-efficiency principles that underpin the NxStage system ... as you have so correctly pointed out..

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    • Mark MacGregor

      Sep 9, 5:20 PM

      Was sad to see the demise of the Aksys, but never understood how the finances stacked up (I guess they didn't). So who owns all the patents now?

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      • John Agar

        Sep 13, 7:12 AM

        Mark ...

        The AKSYS patents sat on a shelf of a development company in NEw Hampshire (DEKA) ... incidentally, the same small flexible development company that designed the Home Choice PD machine for Baxter ... See: http://www.dekaresearch.com/homechoice.shtml ... from the AKSYS demise in 2006/7 until DEKA was 'acquired' by Baxter in c.2010. This gave Baxter full access to the AKSYS patents and jump-started their Vivia venture using many of the original ingenuities of the AKSYS system.

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        • Dave

          Sep 18, 9:34 AM

          DEKA was not acquired by Baxter in 2010 and remains a stand alone company owned by Dean Kamen today.

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          • John Agar

            Sep 19, 12:04 AM

            Sorry if I misrepresented that. My error.

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  • Dori

    Sep 8, 4:08 PM

    That's a great insight, Mel, and it adds a lot to our understanding of what may have happened. Perhaps you recall the RenalSolutions sorbent machine from the early 2000s? It was also nicely designed with the fluid and electromechanical systems separate. Fresenius bought the technology, but instead of developing it, they decided to try to integrate sorbent into their regular machines (this would be great for, say, disaster situations--just load a bunch of them on a truck and dialyze folks with a generator and very little water). That hasn't made it to market, either, the fellow spearheading it within Fresenius retired, the team broke up, and I haven't heard a status update in several years...

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    • John Agar

      Sep 13, 7:31 AM

      Dori ...

      As a member of the RenalSolutionsInc MAB, I actually thought it a good machine and was disappointed when it was bought by Fresenius. Conspiracy theories aside, it was not clear to me at the time whether it was bought to speed up the development of a portable sorbent system ... i.e. what emerged (for a time) as the PAK prototype ... or to silence or sideline a potential commercial threat. That distinction - to my mind - remains uncertain to this day.

      As Dori notes, it was, again in my view, a retrograde step to merely scavenge parts of the well-research, well-developed, nicely designed Renal Solutions sorbent-based Allient Eagle to graft onto the outside of an existing Fresenius machine when the Eagle was already trained to fly.

      Then when the PAK fell silent after the FDA sent it back to Fresenius for more work - especially around intra-dailytic sodium ramping - and its management team dispersed, it seemed clear (to me) that there was no Fresenius heart in sorbents.

      Nothin has changed my take on this since to make me think otherwise. And ... that is sad, I think. Certainly all 'portability and/or wearability' efforts are currently being based round sorbents ... the WAK, the AWAK, and a couple of others I won't mention ... so, to seem to have bogged down (or mothballed) the PAK seems both odd, and sad.

      Maybe there are things afoot (in Demark? ... pardon my Hamlet) that we are not privy to, though, if so, the secret is being tightly held.

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      • Dave

        Sep 18, 9:39 AM

        John, you have touched on the pivotal point in this conversation. How many devices have been approved by the FDA since they altered their 510k evidence requirements c. 2008/2009? The answer to this is the root cause why R&D in this space yields no commercial product release.

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    • Mel Hodge

      Sep 8, 9:01 PM

      If I were a suspicious person, (which I usually am not) I would wonder about Fresenius' motives in acquiring the Renal Solutions sorbent machine rights. Consider the current practice where the pharmaceutical companies bribe the generic companies to stay out of the market after the original patents expire in order to extend the high profit margins that they enjoy as the sole supplier of important drugs.

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      • John Agar

        Sep 13, 7:13 AM

        Be suspicious!

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  • Melville Hodge

    Sep 8, 1:22 PM

    John, my diagnosis is somewhat different than yours -- undoubtedly because my background is in engineering and running Silicon Valley technology companies, not medicine.

    The proximate cause of death was bringing in a new "turn-around" CEO, who undoubtedly went through all of Baxter's products and projects with a simple rule like -- "Get rid of anything that is not -- or will not -- produce an operating profit in (say) two years above a certain threshold." It is unlikely this reflected any great insight into the home dialysis market -- only the mandate he was given by the board when he was hired. Thus, I don't think any implications about the home dialysis market can be drawn, save one -- NxStage is free -- if someone else doesn't pick up VIVIA -- from a deep pocketed competitor.

    The underlying cause of death may have been ignoring one of the two great strategic pillars of NxStages's success (certainly not dialysis efficacy which is significantly worse than the in-center machines because of far too low a dialysate/blood ratio, something I hope will be corrected in their new machine).

    The first pillar is complete separation of the fluid and electro-mechanical systems. Electronics hates moisture. . This separation allowed NxStage to build very reliable systems. From my experience the NxStage machine is at least an order of magnitude more reliable than the Fresenius 2008K (I don't miss the flooded bedrooms). In the early years when their dialysate was limited to pre-filed bags, it also avoided the need to solve the dialysate preparation problem, thereby simplifying their initial product.

    The second pillar was to base their business on a "swap out" maintenance philosophy, avoiding any need for "in-home" maintenance. This let them use United Parcel Service or Federal Express as their maintenance arm and concentrate all their skilled service personnel, test equipment and parts inventories in central locations. While you see NxStage portability as a patient convenience, I see it as a necessary requirement to have made the "swap out" strategy work (along with the requirement to make the water unit a separate unit). My business judgment tells me it is probably impossible to build a successful home dialysis product business, if it relies on in-home maintenance.

    Yesterday, Apple (just down the road from me) had its ANNUAL product launch for new iPhones. Last year NxStage promised a launch of its new system this year, 14 years after launching its present system... This kind of logical behavior by NxStage is the high price we might pay for Baxter deciding to put its stock price above entering the home market, a market that badly needs competitors. I hope that others don't read this decision as a negative commentary on the home market -- as it is not. The evidence continued to mount that the days of short, infrequent aggressive dialysis are numbered. Unfortunately, it is the patients who pay the price of waiting.

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    • Henry P Snicklesnorter

      Sep 13, 9:57 AM

      I wonder if Baxter have simply seen 'the writing on the wall' regarding the finite future of bulky dialysis machines, (Including NxStage,) and is preparing to invest its considerable resources in the next iteration of dialysis treatment devices which are either implantable or so small and light that they can be worn by the patient. I personally believe that we are very close to this becoming a reality, - and when it does, dialysis machines as we know them at present, will be something we look back on without regretting their passing. I see a future with NO in-centre dialyis and all dialysis machines, (in whatever form they take,) being used at home by virtue of their miniaturisation to the extent that the user carries them with them all the time and they operate continuously.
      Dialysis 24/7. Its a lovely thought.

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