Technology: What’s Coming
The Fresenius portable sorbent system (the “PAK”) …
NB: Conflict of Interest … the author of this website is a member of the Medical Advisory Board of Fresenius RSI, USA
In 2007, Fresenius first ...
– Acquired Renal Solutions sorbent technology and, two years later, the intellectual rights to Xcorporeal in 2009
– The Renal Solutions Inc sorbent-based Allient system was ‘blended’ with features of the Xcorporeal system and the Fresenius Baby-K
– The result ... a portable sorbent-based system – the PAK
– The PAK is currently before the FDA for approval as a home HD machine
– Clinical trials are expected in 2013.
The PAK provides sorbent-regenerated HCO3 dialysis fluid using:
· Sorbent technology to continuously renew the dialysis fluid
· A dialysis flow rate of 150 to 500 ml/min
· Allows blood flow rates of 100 to 600 ml/min
· Is a truly portable dialysis system by splitting into two halves …
o A 20.4 kg pump unit
o A 10 kg reservoir unit
It also features:
· A disposable cartridge with dialysis fluid lines, blood lines and HFAK
· No air blood interface which, like the NxStage, reduces heparin requirements
· Has a wipe-down to disinfect casing
· Has automated prime and rinse back
· Has a heparin pump and a medication port
· Allows data storage
Time will tell …
… these and other questions remain to be answered.
One thing seems certain …
The options and competition in the home dialysis market will, in the next 3-5 years – be both fierce, and welcomed.
Home HD – and in my view, ideally long, slow, frequent home-based and overnight dialysis – is back … and it has been too long coming.
Baxter’s Home HD system …
Baxter partnered Deka in late 2007. This gave Baxter access to the Aksys patents owned by Deka.
Deka, itself, is a most interesting company ...
· among other inventions, it gave us the Segway ...
and, more importantly for dialysis ...
· it gave us the Baxter Home Choice machine that back-boned automated peritoneal dialysis (APD).
There has been an air of mystery about the Baxter home HD machine – though it is now before the FDA. While some of us have seen it and are aware of its’ features, commercial-in-confidence agreements bind those who have already been exposed to it.
What can be said is that while it is a relatively standard-sized dialysis system, it has taken the old hot water sterilization processes of the 1990s Aksys and turned it into 2012+ technology.
· It uses hot water sterilization
· The consumables – like with the old Aksys – only need to be changed once a month ... lines, dialysers, water filtration systems ... the whole shooting match.
· It is entirely a one patient + one machine system ... the consumables clearly cannot be used for anyone other than for the patient who first used them without changing the entire circuitry and, as such is, an ultimate one patient, one home system.
· While it is clearly not a portable system – its’ water processing technology is ‘on board’ in the lower half of the machine – it is a stand alone system.
· It does not need additional water systems outside the ‘box’ of the machine.
· There is no clumsy filtration and reverse osmosis equipment outside the machine casing.
· And … it does have some nifty ‘new-to-dialysis-systems’ features.
But ... what is exciting is that here is yet another machine – soon to be available – that will enhance and enliven the home dialysis market-place.
So ... yes ... home haemodialysis is finally alive and well outside the historical home of home haemodialysis in Australia and New Zealand!
The Quanta Self-care+ ...
The Quanta is a UK system that is now in clinical trials. It is a single pass dialysis system and does still require water preparation with an external, though streamlined, R/O support process.
The Quanta website is ... http://www.quantafs.com/
The Quanta, as a machine, has been ‘shrunk’ and while I have not personally been up close and personal with it – that personal pleasure won’t occur until October 2012 – it has some features of which I am aware ...
As with the other emerging home dialysis systems, it will need to compete in an active market and find its place among the several systems that will soon be on offer.
Exciting times ....
The AWAK peritoneal dialysis system ...
The AWAK is an Automated Wearable Artificial Kidney ... an automated, 24 hour a day, 7 days per week continuous peritoneal dialysis system.
It has been developed in Singapore and has been on show – in prototype format – at most major nephrology gatherings since 1st being demonstrated at the 2009 ASN in Philadelphia.
It, too, uses sorbent technology. Sorbents are around! ... and we will need to become more familiar with how they work and their dialysis-related possibilities (and limitations). As noted previously with the Fresenius PAK portable HD system, sorbent technology is at the core of many of the recent attempts to miniaturize dialysis and separate dialysis from a major water-source.
The following diagram is taken from the AWAK website.
The AWAK can be seen at their website = the source of the following material.
The following quote comes directly from the AWAK website and is in the public domain ...
The AWAK has recently entered paediatric trials in Germany – the outcomes of which will be eagerly awaited in peritoneal dialysis circles
While these notes inform about some of the advances being made in dialysis technology, they are by no means comprehensive.
There are other developments happening.
What is clear is, that after 50 years in a technology doldrums where not a lot changed other than monitoring advances for single pass systems, finally technology innovation is alive and well again.
And ... while it may not come fast enough for any of us ... it is coming!
Authored by Prof John Agar. Copyright © 2012