A new Kid(ney) prepares to blast off - the Quanta SC+

This blog post was made by Dr. John Agar on January 15th, 2015.
A new Kid(ney) prepares to blast off - the Quanta SC+
By John Agar (who is on the Quanta Medical Advisory Board)

On the 6th January, 2015, Quanta Fluid Solutions, a company based in Warwickshire (UK), put out a press release to announce the success of their application for CE mark approval for their new portable home dialysis system; the Quanta SC+.

So, what does a CE mark mean, and not mean?

  • A CE mark on a product is a manufacturer's declaration that the product in question, in this case, the Quanta SC+, complies with all/any of the essential “product directives” that may be required by European health, safety and environmental protection legislation.
  • The “product directives” include both certified "performance standards" and "harmonized standards" – the latter indicating the technical specifications of the equipment.
  • Any equipment bearing the CE mark must conform to both sets of standards. These standards are set and supervised by the European Committee for Standardization (CEN) and the European Committee for Electro-technical Standardization (CENELEC).
  • A product bearing a CE mark indicates to governmental officials from any country within the European Union (EU) that the product may be legally placed on the market in their country.
  • A CE mark on a product ensures the free movement of the product within countries of the European Free Trade Agreement (EFTA) and the EU, a single market comprising a total of 28 countries.
  • While a CE mark does not guarantee approval by regulatory bodies outside the EU—for example, the FDA in the USA or the TGA in Australia—the acquisition and attachment of a CE mark does confer a significant advantage to any equipment being submitted to these regulatory bodies, and assists the passage of equipment through their approval processes.

The Quanta SC+ press release can be found at: http://www.quantafs.com/news-events/press-releases/

This press release is well worth reading. It describes a machine that is small (37 x 45 x 48 cm, or 14.5 x 18 x 19 inches). This is similar in size to the NxStage machine (38 x 38 x 46 cm, or 15 x 15 x 18 inches), though in contrast to the NxStage system, The Quanta SC+ employs standard and conventional single-pass dialysis techniques.

The innovative step in the Quanta SC+ is the disposable cartridge system , which incorporates four pneumatic pump chambers that externalise both the blood and dialysate flow pathways and drive their flow mechanisms (see picture below: courtesy Quanta SC+). Those who will be attending the ADC in New Orleans later this month will be able to inspect the Quanta SC+ and hear it presented at Bob Lockridge’s regular New Technology session (Sunday 2.00-4.00 pm).

Quanta SC+ Haemodialysis Machine Schematic

This picture shows the drop-in cartridge with the 4 x pneumatic pumps

If comparing the Quanta SC+ with the NxStage system, it is important to consider the two prime appeals of NxStage: (1) portability, and (2) reverse osmosis (RO) independence.

As regards portability, the Quanta SC+ certainly offers a comparable portable option . While both systems are similar in dimension (see above), the Quanta SC+ is a little lighter, weighing ~30 kg (66 pounds) compared to the NxStage ~34 kg (75 pounds). This places both systems in an aircraft-suitable luggage range.

But, as regards the dialysate, unlike the NxStage system, the Quanta SC+ still requires RO for water preparation. While on the face of it, this may seem to confer a disadvantage to the Quanta SC+, the SC+ provides “as-we-know-it”, single-pass, on-line, high-flow, bicarbonate dialysate with dialysate flow rates up to 500 ml/min—a rate familiar to all dialysis services. The Quanta SC+ thus permits the usual ratio of dialysate flow (Qd) to blood flow (Qb): a Qd:Qb ratio of 2:1.

On the other hand, the dialysate volume of the NxStage system is much more “limited”: the maximum available dialysate volume being 30L (if using System One with bagged dialysate) or 60-80L (if using an on-line PureFlow™ dialysate generator). In either circumstance, Qd is significantly restricted and the usual Qd:Qb ratio must be reversed to a ratio of 1:2 or even 1:3. In turn, this demands blood to be drawn from and returned to the AV access (Qb) at 400 ml/min or more, flow rates that are often unattainable, and may even be harmful to the servicing vasculature of the AV access, whatever its anatomical site.

Dialysis must have dialysate in one form or another. While conventional systems use RO to purify tap water prior to the creation of the dialysis fluid—usually now called the dialysate—the NxStage system circumvents this problem by providing “travel bags” of pre-formed dialysate (usually 5 or 6 x 5L bags per treatment, or by adding an online (but not portable) dialysate generator, the PureFlow™. However, sourcing or transporting 30L of bagged dialysate if “on the road”, while doable, is still a hassle.

While clearly the Quanta SC+ still needs RO, quiet, small and relatively inexpensive individual RO systems are now available . While portable dialysis-grade RO systems are now available—the smallest I am aware of is the Aquaboss® (Eco)RO Dia 70 system = 50 x 39 x 19.5 cm (or 19 ½ x 15 ½ x 7 ½ inches), weight 35 kg (77 pounds)—it is clear that even smaller and more portable RO systems could soon eventuate. This would allow realistic, on-the-go, facility-grade, single-pass dialysis paired with a truly portable RO. In the meantime, if a home-based patient primarily seeks to dialyse at two sites (e.g. home and a weekender cabin), two individual RO systems could be quite cheaply installed —one at each dialysis venue—with the dialysis machine then being transported between them.

One significant advantage for the Quanta SC+ lies in its use of conventional, well understood, facility-grade dialysis principles. This means that wherever dialysis is undertaken, the same machine, familiar to all—both staff and patients alike—can be seamlessly used across all site platforms. This negates additional training, translation of (and potential confusion with) dialysis principles, and minimises maintenance costs. As regards the latter, the Quanta SC+ is a “dry” system, and the machine maintenance that goes with de-scaling, sterilisation etc. is averted.

To summarise, the Quanta SC+ holds out the promise of providing a seamless space-saving dialysis option—both in-centre and at home—while using dialysis principles and flow rates that are familiar to all, and providing clearance profiles consistent with best-practice dialysis without the need for staff or patient re-training .

While the Quanta SC+ is yet to be brought to the commercial market, and further live testing and fine-tuning will be essential before this machine can be offered to dialysis providers for general patient use, the acquisition of the CE mark is a huge step along the way to the Quanta SC+ becoming an exciting new addition to our dialysis “furniture”.

Quanta SC+ Haemodialysis Machine

Comments

  • Benahmed Abdallah

    Jan 10, 1:43 AM

    I'm looking forward to 've one; can you please tell me how much it cost (1quanta sc+ & 1 RO system) ?

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    • John Agar

      Jan 10, 5:03 PM

      Benahmed ...\

      My response is the same as the ones to Richard and Sonya (see below). While Quanta SC+ is coming, and has completed its clinical trials in the UK, it will only be commercially offered - and first only in the UK - at a time of choosing for the company that is developing it. It will not be available outside the UK until such time as the company is ready to move off-shore. This is, I think, exactly as I have responded(below) ... and there is no change to that time frame.

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  • Chris

    Sep 22, 10:14 AM

    Looking forward to using this on my road trip I am planning

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  • John Agar

    Jul 7, 6:25 PM

    I think I have answered you as well as I can already.

    While the trials are all but complete now, the timing of a commercial release is a Company decision. It in not just a matter of ticking off on the machine. Support services must be financed and set up. Distribution processes must be financed and set up. Manufacturing must be financed and set up. Quality control must be assured. These and other commercial and practical steps are in the hands of the company. Undue haste to release may jeopardise success. In addition, it is no mean feat - in ANY business venture - to secure and ensure the adequate investment to underpin these processes.

    I cannot give more information other than to say that a methodical process is in place, and the machine and the company behind it is sound, and meeting each target as it progresses to a UK release.

    Moving off-shore to other countries also takes time. NxStage took about 7 years (if I remember correctly) to make its first move ex-USA. I am unable to give you any idea or clue to how long it may take Quanta to do the same ex-UK. I know you are anxious to see new technology, but this is the best I can do ...

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  • Sonya Watt

    Jul 3, 4:44 PM

    When will the Quanta SC+ be available in Australia and how much will it cost?

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    • John agar

      Jul 5, 5:43 PM

      My response has to be the same as it was to Richard. It is a UK machine, and is currently undergoing and acquiring increasingly wide clinical trial experience in the UK only. Once all clinical trials are complete (over 12 months data so far) and then at a time to be determined by the Company, it will then become commercially available. This then requires robust sales, servicing and distribution systems - again, to be established, tested and perfected - and again in the UK. Only then might there be any likelihood or reality of expansion beyond the shores of that little island. This is the way most products - of any kind - progress through invention, to prototype, to practical item, to trials and tests, to limited release, to support structures, to local markets, and ... if all systems are then still on 'go' ... to wider commercial release. This is a slow process - and for those awaiting promising medical devices, can be agonising. I understand that. But, it is reality. What I think I can say is that it remains on track, it is ticking off each of its milestones along the way, and it continues to progress through the agonisgly slow but necessary steps to commercial release. And, while this will also be UK-centric to start with, Australia is a very likely second market. The only two non-UK members of the Medical Advisory Board are Australian (myself and Peter Kerr) ... a factor that places our services in a strong position to seek first-offshore status ... though even then, this is a decision entirely for the Company, and no others, to take. So ... frustrating and slow it must seem, but in the end, a well tried, tested, and validated machine is essential if it is to stand strong and long in the market place and, while medical devices are seen differently by user and manufacturer, the manufacturer has a commercial role to play, and we MUST allow that role to play out robustly ... and safely.

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      • Sonya Watt

        Jul 7, 3:27 AM

        How long before all trails be completed? Are we talking years or months and how many years or months?

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  • John agar

    Jan 24, 4:06 AM

    Dear Rochard

    As the blog states, the Quanta SC+ still has human trial data to accumulate, and, even then, will likely be released in the UK/European market first ... though those decisions are not mine to make.

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  • Richard Douglas

    Jan 23, 3:36 AM

    This sounds like it could change my life! I cannot wait for this machine. When and where will it be available?

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