Artis Physio™ systemBecause every patient is different

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Artis Physio™ systemBecause every patient is different

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As the leading pioneer and innovator in dialysis, Gambro is proud to introduce you to Artis Physio, an advanced in-center chronic hemodialysis system that provides Individualized Quality-assured Dialysis (IQD™).

The Artis Physio dialysis system is inspired by Gambro’s passionate commitment to hemodialysis. It provides an unmatched range of treatment modalities to meet patient needs through innovative technologies that simplify everyday operations, and enhance user experience.

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With IQD you can choose and adapt the right therapy to the patient’s needs while being confident that the treatment is easily and effectively delivered and clinical targets are consistently reached.

IQD is all about making a difference to the daily lives of you and your patients.

Individualized treatment: overcoming the hemodialysis challengesDespite many advances in hemodialysis therapy (HD), dialysis-related complications, such as intradialytic hypotension (IDH), faintness and fatigue are still frequent and can profoundly affect treatment tolerability, efficiency, and outcomes. Complications associated with end stage renal disease vary between patients and the same dialysis modality for all patients does not adequately address individual patient needs.1–6 Choosing a treatment modality tailored to your patients’ needs can improve short- and long-term outcomes. In Gambro we believe that IQD is the best approach to ensure that every patient can benefit from best possible care at every session:

• A treatment modality answering individual clinical challenges

• Fewer dialysis-related complications• Better treatment tolerability• Consistent treatment delivery and outcomes

Individualized Quality-assured Dialysis

The Artis Physio™ system offers individualized dialysis and the freedom to choose the optimal treatment modality to meet your patients’ needs.

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Individualized treatment with the Artis Physio dialysis systemThe Artis Physio dialysis system provides all necessary treatment modalities and tools to take full benefit of IQD. It combines technological innovation with clinical expertise to offer an unmatched range of unique functions such as the BiCart Select Citrate system, the HemoControl and UltraControl™ treatment modalities.

BiCart Select™ Citrate systemThe acetate-free, citrate-containing dialysis fluid provides a whole range of benefits for better patient well-being.

• Improved tolerance to treatment7

• Improved acid-base status9

• Less thrombogenic dialysis9

HemoControl™ treatment modality This unique modality manages fluid removal in a more physiological way reducing the number of IDH.

• Minimized cardiovascular stress reducing the risk of IDH12 • Improved treatment tolerability and shorter post-dialysis

recovery times26

UltraControl™ treatment modalityThis ‘one-button’ hemodiafiltration (HDF) modality ensures consistent high convective volumes in HDF post dilution at every session.

• Automated delivery of high volume post dilution with minimal alarms and nurse interventions28

• Lower risk of all-cause mortality with high-volume HDF19, in targeted patient groups

Artis Physio™ system – Because every patient is different

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The Artis Physio™ system provides a range of modalities that reduce treatment complications and improve patient comfort.

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The BiCart Select Citrate system offers a safe and biocompatible replacement of acetic acid to provide citrate-containing dialysis fluid.

Patient comfort mattersThe level of acetate in standard bicarbonate dialysis fluid is much higher than the normal plasma level and this can promote hemodynamic instability, inflammation, and post-dialysis malaise.

Citric acid is a natural metabolite, and antioxidant with anti-inflammatory properties, that can be used as a more biocompatible acidifier for dialysis fluid.

Replacing acetate with citrate in dialysis fluid may benefit all patients receiving hemodialysis and hemodiafiltration.7–9

• Improved patient comfort and tolerability of treatment • More efficient management of patient acid-base status• Reduction of dialysis-induced thrombogenicity

BiCart Select Citrate system improves tolerance to treatment In a clinical study using SelectBag™ Citrate concentrate, citrate dialysis fluid reduced the intradialytic rise in pentraxin-3 (PTX-3), an inflammatory marker known to be induced by hemodialysis treatment.9

BiCart Select Citrate system: one step to a better working environmentThe unique Gambro BiCart Select system is an effective solution for a tailored prescription of the electrolytes in dialysis fluid for less than 3 kg of concentrate per treatment. Compared to conventional liquid concentrates, the BiCart Select system offers several benefits:

• Higher accuracy in treatment individualization; sodium and bicarbonate can be adjusted independently from the other ions

• Improved safety and hygiene• More convenient handling, easier storage, and logistics

BiCart Select™ Citrate system improves tolerability for all patients

BiCart Select Citrate system provides biocompatible, acetate-free, citrate-containing dialysis fluid, which improves the tolerability of treatment.

2 ∆

PTX

-3 (n

g/m

l)

1

Citrate0

Significantly lower intradialytic rise in PTX-3*,indicating higher biocompatibility9

Control*Pentraxin-3

P = 0.04

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Improving patient comfort*

M.J. is 62 years of age and has been receiving dialysis for one year.

She was experiencing frequent headaches as well as general lethargy and sleepiness.

She is now being treated with the BiCart Select™ Citrate system, and her symptoms have become milder and less frequent.*Illustrative clinical case

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The HemoControl modality can reduce the risk of dialysis-related hypotension for a more efficient session.

Intradialytic hypotension: a daily concernEpisodes of intradialytic hypotension (IDH) can occur in up to 30% of hemodialysis sessions with significant burden on the clinic and patient. IDH places severe strain on the cardiovascular system, which may cause temporary ischemia in many organs. Importantly, dry weight may not be achieved, and the patient will not receive an adequate dialysis dose. Together, these effects can significantly reduce life expectancy.

HemoControl: a unique treatment modalityThe HemoControl modality removes fluid according to the physiological tolerances of the patient. IDH is often due to an impaired response of the cardiovascular system to fluid removal resulting in a fast reduction of blood volume. The HemoControl modality is unique in that it proactively controls the blood volume reduction by regulating ultrafiltration rate and dialysate sodium. This keeps the blood volume in a physiological range and reduces the risk of intradialytic hypotension.10–14

39% of IDH episodes can be avoided byusing HemoControl modality14 The smooth and adapted fluid removal with the HemoControl modality improves session tolerance and treatment outcomes10–15:

• Reducing the number of IDH episodes by 39%• Reducing stress on the cardiovascular system• Improving patient tolerance to treatment• Reducing the number of nurse interventions

Significant reduction in the risk of intradialytic hypotensionBlood volume control can effectively reduce IDH during dialysis. A meta-analysis of randomized controlled clinical trials examining the efficacy of biofeedback modalities, demonstrated a 39% reduction in frequency of hypotensive episodes compared with standard hemodialysis.11,14

HemoControl™ modality reduces the risk of intradialytic hypotension

The HemoControl modality reduces intradialytic hypotension for an improved treatment outcome.

5210.50.2

Total (95% CI)

Crossover trialsBegin 2002Gabrielli 2009Santoro 2002Selby 2006Subtotal (95% CI)

Study or subgroupParallel trialsDeziel 2007Nesrallah 2008Subtotal (95% CI)

Rate ratioIV, Random, 95% CI

The HemoControl modality versus conventional HD with constant dialysate conductivityand ultrafiltration rate; outcome: IDH, relative treatment effect estimate

Favorsconventional HD

FavorsHemoControl HD

39%reduction in the incidence of IDH with the HemoControl treatment modality14

P = 0.005

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Reducing intradialytic hypotension*

N.P. is 67 years of age. He has been receiving dialysis for eight years, he often has significant interdialytic weight gain.

He used to experience frequent episodes of IDH during dialysis sessions that required nursing intervention and made it difficult to reach his optimal post-dialysis weight.

He now benefits from the HemoControl™ modality: the frequency of IDH has been reduced, resulting in fewer treatment disruptions and a shorter recovery time after treatment.*Illustrative clinical case

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The UltraControl modality makes it simple to reach high volume post-dilution HDF session after session.

Clinical benefits of high volumepost-dilution HDFThe ESHOL clinical trial has demonstrated improved survival and a lower hospitalization rate for patients treated with high blood flow rate and when high volume post-dilution HDF can be delivered consistently.19 Although this sounds simple, the routine implementation poses challenges such as excessive hemoconcentration and subsequent high pressure alarms, or even clotting. The variability in treatment conditions forces the use of an automatic system with automated control of the transmembrane pressure (TMP) in order to maximize the convective volumes while maintaining a smooth and event-free session.

UltraControl: a unique treatment modalityThe UltraControl modality makes high volume post-dilution HDF simple. This unique technology for HDF post-dilution performs regular and automatic TMP scans to determine the optimal TMP value and makes all the necessary adjustments to maintain the optimal filtration performances of the membrane. The session can be completed with no pressure alarms, manual adjustments are minimized and the total convective volume is significantly higher compared with conventional HDF systems.16,17,18

Simple, safe and effective high volume post-dilution HDF with the UltraControl modality The Artis Physio™ system offers the benefits of the UltraControl modality at the touch of a single button and makes it possible to consistently deliver high volume post-dilution HDF at every session.

Increasing life expectancy High volume post-dilution HDF offers superior blood purification capacity over the full range of solutes, from urea to ß2-microglobulin, and reduces the risk of all-cause mortality.19 Sensitivity analysis of the ESHOL study data indicated that the favorable effect of HDF was pronounced in patients with a high comorbidity index.19

Interaction between the HDF effect on all-cause mortality and patients’ Charlson comorbidity index (excl. diabetes).Graph adapted from original publication of the ESHOL study results19

Polyflux™ H dialyzer: optimized for HDF outcomesThe Polyflux H dialyzer from Gambro offers benefits of particular value in post-dilution HDF treatments. The Polyamix™ membrane’s asymmetric 3-layer structure provides excellent sieving properties and precise cut-off, ensuring optimal balance between clearance and retention of albumin and other essential proteins. With a membrane designed for convection, the Polyflux H dialyzer is the natural choice of filter for treatment with the UltraControl modality.

UltraControl™ modality provides high volume post-dilution HDF in one touch

The UltraControl modality delivers high volume post-dilution hemodiafiltration, reducing mortality in targeted patient groups.

Charlson Index

Low tertile

Mid tertile

High tertile

0.10 1.00 10.00

0.022

Hazard ratio (95% CI)

Interaction between the HDF effect on all-cause mortality and patients’ Charlson comorbidity index (excl. diabetes).Graph adapted from original publication of the ESHOL study results19

P-value forinteraction

OL-HDFbetter

HDbetter

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Taking the benefits of high volume post-dilution HDF*

S.T. is 66 years old, and has been in dialysis for 6 years. Her A-V fistula works well.

She has chosen not to go on the list for kidney transplantation.

She has now been receiving post-dilution online HDF for 18 months; with a blood flow rate of 380 ml/min and thanks to the UltraControl modality, the convective volume is consistently above 23 liters. She recovers quickly after dialysis and she hasn’t been hospitalized since starting on HDF.*Illustrative clinical case

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Artis Physio™ system allows you to achieve your treatment goals consistently

Because every session is differentHemodialysis is a complex process that is not always under adequate control leading to significant variability in the delivery of the prescription, which can reduce the potential clinical benefits for the patient.

A quality-assurance approach is required to ensure that the therapy is effectively delivered.

Quality-assured dialysis Developed using our extensive experience in the hemodialysis clinical environment, the Artis Physio dialysis system provides a unique blend of established and innovative technologies that you can rely on to consistently achieve the treatment goals for your patients:

• Automated processes for reliable and effective compliance to clinical procedures

• Accurate setting of treatment parameters with intuitive user interface and Patient Card

• Early detection of any deviation from prescription with the Diascan™ monitoring system and SmartScan feature

• Automated and predictable sessions with HemoControl™ and UltraControl modalities

• Comprehensive summary of treatment data for traceability and clinical analysis

Consistent delivery of prescription The advanced technology integrated in the Artis Physio dialysis system offers more than the comfort of smooth treatments; with a set of tools aiming at quality-assured dialysis, the variability in treatment delivery can be reduced, contributing to improve clinical outcomes. With the Artis Physio system, the most effective modalities can be used routinely with no additional burden on the clinical staff and treatment goals are met reliably session after session.

The Artis Physio™ system allows you to achieve your treatment goals consistently.

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Delivering the prescribed dialysis dose in due time Consistently achieving the dialysis dose will reduce the risk of all-cause mortality and is essential if patients are to receive the benefit of treatment.23–25

The Diascan™ monitoring system is an integrated feature of the Artis Physio dialysis system that provides an accurate and real-time measurement of the dialysis efficiency: early indication of thetreatment result is provided for optimization of settings if necessary, allowing to reach treatment goals at each treatment.20–22

Predictable and efficient sessionsThe reduction of IDH with the HemoControl™ modality significantly increases the number of event-free sessions. The prescribed post-dialysis weight is achieved with less complication,27 making the session more effective and predictable. Patients also benefit from a shorter recovery time,26 facilitating post-treatment procedures.

Consistently achieve high volume post-dilution HDFThe UltraControl modality is a simple, safe, and effective approach to HDF. The complex adjustments required for HDF post-dilution are handled automatically by the UltraControl modality to ensure high convective volumes session after session.18, 28 Treatments run with minimal alarms and nurse interventions, compared with systems driving infusion volume without TMP control.

60

50

Ioni

c K

/ Qb

ratio

(%)

Access recirculation (%)

40

30

20200 40 60 80

The ratio ionic clearance (Ionic K) / blood flow rate (Qb) is useful to identify recirculation in the vascular access , one of the major cause of impaired delivery of dialysis dose

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29.2

50.8

0102030405060

Standard dialysis With HemoControlmodality

Even

t-fr

ee s

essi

ons

(%)

74%increase in event-free sessions with HemoControl modality27

P < 0.01

+6%increase in convective volume18

10

15

20

25

30

No TMP control With UltraControl™ modality

Infu

sion

vol

ume

(l)

*Trans-membrane pressure

P < 0.029

21.823.2

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Artis Physio™ system: designed for the users

The modern dialysis clinic is a demanding environment. New technology makes a real difference when it simplifies routine maneuvers and reduces the strain of daily work.

The user-centric and ergonomic design of the Artis Physio system makes it easy and pleasant to use, while maintaining the effectiveness of the clinic.

Handling is intuitive, you can feel confident that the most advanced tasks can be quickly learned and easily implemented, freeing up time for the task that really matters – caring for your patients.

Take control of the treatmentThe Artis Physio system is easy to use, with its unique NavPad™ interface and intuitive help-on-screen feature.31

The five-button NavPad mirrors the normal steps of treatment delivery allowing you to access critical information logically. You can easily navigate to all working environments, allowing you to manage prescriptions, supervise treatment, access blood and fluid settings, as well as generate treatment reports.

The help-on-screen feature provides step-by-step instructions, guiding the operator through the optimal handling when running unusual procedures.

Naturally aligned with workflow

Logically grouped by function

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ArtiSet™ blood circuit: one-button set-upDressing the Artis Physio system is fast, safe, and easy with the ArtiSet integrated blood circuit, which also allows one-button auto-priming.30

Unlike conventional blood circuits, the ArtiSet blood circuit requires fewer procedural steps to set up and the priming procedure is initiated at the touch of a single button.

All operator actions are grouped in one single sequence to prevent waiting times. There is no need to rotate the dialyzer or adjust levels in the chambers, and priming fluid is automatically drained using the Evaclean function, eliminating the handling of waste bags.

ULTRA Prime function: streamline processesThe Artis Physio system can help streamline workflow in the clinic, reducing time spent operating the system.

The ULTRA Prime function filters the dialysis fluid through a sterilizing membrane that also retains endotoxins*. It provides fluid suitable for priming, bolus, and rinseback in HD mode. Sterile saline bags are no longer needed, simplifying storage, logistics and handling.

* the fluid delivered by the system complies with the requirements set by the European Pharmacopoeia concerning the endotoxin limits for infusion fluids.

Artis Physio™ is a user-friendly and efficient system that puts you in control of the treatment delivery.

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Artis Physio™ is morethan just a dialysis monitor

At Gambro, we know that the delivery of high-quality treatments requires more than an efficient dialysis machine; the effective integration in the working environment is also crucial. The Artis Physio dialysis system incorporates all Gambro’s dialysis experience and uses proven technology to ensure that every patient can benefit from best possible care at every session.

The Artis Physio system allows the user to take advantage of Gambro’s experience in maintaining fluid quality throughout the entire hygienic chain of components and processes involved in dialysis.

• Proven and highly efficient heat disinfection • Programmable disinfection with full auto-stop and

auto-start• Synchronized process with the Gambro Central Water Plant

for end-to-end disinfection• Disinfection history for quality control and traceability

The Artis Physio system is designed to operate with the CleanCart™ cartridge allowing easy and efficient daily cleaning, disinfection, and decalcification; removing the need for chemicals to be present in the dialysis room.

The Hygienic Chain: 30 years of pure water for you and your patientsWater quality is a critical factor in dialysis care. Contaminants in the water can affect the efficiency of therapy, performance and maintenance of equipment.

Gambro has designed its entire dialysis offering to protect your patients from the hazards of water contaminants and to help you provide the most beneficial dialysis treatment for your patients.

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Maintenance and support made simpleMaintenance has never been simpler. The modular design of the Artis Physio system allows access to all aspects of the system.

The integrated service interface provides you with a range of powerful tools, including presets, calibration, and troubleshooting features. A real-time recording of technical parameters is also stored in an exportable BlackBox for advanced off-line analysis.

As part of the Gambro family, you can rely on our unparalleled customer support to ensure efficient maintenance procedures and minimized downtime.

Advanced connectivity for simplified workflowToday’s clinical environment strives for digitization, improved quality control and operational efficiency. The Artis Physio™ system is ready to address this challenge.

Connectivity to the Artis Physio system allows seamless integration to your IT network. Treatment data can be easily transferred and stored for traceability and quality assurance.

Data can also be accessed for off-line analysis to better manage clinical outcomes for every patient, individually.

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Artis Physio™ system optimized ergonomics

The modern and innovative design of the Artis Physio dialysis system is recognized by healthcare professionals and patients, and makes the treatment room a more pleasant and relaxed environment. The Artis Physio system is more than the sum of its parts; with help from human factor engineering and applied research in physical and cognitive ergonomics, life in the clinic actually does get better.

References1. Dor A, et al. Int J Health Care Finance Econ 2007; 7:73–111; 2. Kramer A, et al. Nephrol Dial Transplant 2009; 24:3557–3566; 3. Caplin B, et al. Nephrol Dial Transplant 2011; 26:2656–2663; 4. Kooman JP, et al. Blood Purif 2012; 33:171–176; 5. Locatelli F, et al. Semin Dial 2010; 23:214–219; 6. Green D, et al. Am J Kidney Dis 2011; 57:921–929; 7. Amore A, et al. J Nephrol 2006; 19:57–64; 8. Daimon S, et al. Ther Apher Dial 2011; 15:460–465; 9. Grundström G, et al. BMC Nephrol 2013; 14:216; 10. Basile C, et al. Nephrol Dial Transplant 2001; 16:328–334; 11. Santoro A, et al. Kidney Int 2002; 62:1034–1045; 12. Selby NM, et al. Am J Kidney Dis 2006; 47:830–841; 13. Déziel C, et al. Clin J Am Soc Nephrol 2007; 2: 661–668; 14. Nesrallah GE, et al. Nephrol Dial Transplant 2013; 28:182–191; 15. Franssen C, et al. Hemodial Int 2005; 9: 383–392; 16. Teatini U, et al. Blood Purif 2011; 31:259–267; 17. Panichi V, et al. Int J Artif Organs 2012; 35:435–443; 18. Meroño R, et al. Diálisis Trasplante 2012; 33:37–41; 19. Maduell F, et al. J Am Soc Nephrol 2013; 24:487–497; 20. Lindsay R, et al. Am J Kidney Dis 2001; 38:565-574; 21. McIntyre CW, et al. Nephrol Dial Transplant 2003; 18:559–562; 22. Mercadal L, et al. Hemodial Int 2005; 9:111–119; 23. Held PJ, et al. Kidney Int 1996; 50:550–556; 24. KDOQI Clinical Practice Guidelines, Am J Kidney Dis 2006; 48 (Suppl.1):S2-S90; 25. Tattersall J et al. Nephrol Dial Transplant 2007;22 (Suppl.22):ii5-ii2; 26. Gil HW, et al. J Am Soc Nephrol 2012; 23 [abstract 233A]; 27. Begin V, et al. ASAIO J 2002; 48:312–315; 28. Albalate Ramón M, et al. Nefrologia 2011; 31:683–689; 29. Mohan, et al. ASAIO J 2010; 56(5):427-433. 30. Garzotto F, et al. ERA-EDTA 2008 [abstract F-PO1573]; 31. Ward RA and Ronco C. Blood Purif 2009; 27:6–10;

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Artis Physio™ is Gambro’s advanced in-center dialysis system. With its range of modalities that reduce treatment complications and improve patient comfort, the Artis Physio system allows you to consistently achieve your treatment goals.

Easily integrated into the clinic, user-friendly and efficient, the Artis Physio system puts you in control of treatment delivery.

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Every patient is different, every session is different

The IQD™ approach is all about making a difference in the daily lives of patients and healthcare professionals

Individualized Quality-assured Dialysis (IQD) from Gambro helps healthcare professionals deliver the best care to every single patient, in every single session. Based on leading dialysis technology and fundamental insights into chronic dialysis care, our IQD offering provides a comprehensive range of treatment modalities and dialysis products for each patient and their individual needs. IQD gives you the confidence that the hemodialysis session is easily and effectively delivered and the target dose is consistently reached while making better use of the clinic’s resources.

Gambro Lundia ABPO Box 10101SE-22010 LundSwedenPhone + 46 46 16 90 00partner@gambro.comwww.gambro.com