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DiacapConstant performance resulting in high quality dialysisAvitum

B. Braun Avitum. Always with Passion.B. Braun is a leading international company in the healthcaremarket. With a long tradition stretching back over 170 years,B. Braun is a global player with more than 41,000 employeesworldwide and branches and subsidiaries on all continents.B. Braun Avitum is a wholly-owned subsidiary of B. Braun and,for over 30 years now, one of the pioneering suppliers of dialysistechnology. In offering complete solutions for extracorporealblood treatment, B. Braun Avitum is one of the leading companiesin research, manufacture, and therapy. Customers and patientsthroughout the world benefit from B. Braun Avitum’s efficientand high-quality dialysis products and services.The head office of B. Braun Avitum is located in Melsungen,Germany. A new B. Braun Avitum plant was also recentlyestablished in Melsungen and this is also where the production ofdialysis machines takes place.B. Braun Avitum is a reliable partner and, in addition to dialyzers,also offers other products, such as the dialysis machine Dialog ,with its innovative options, such as Adimea, the data managementsystem Nexadia, as well as all consumables; it has, therefore, become established as an integrated and trusted system provider.In addition to its role as supplier of dialysis systems, B. Braun Avitumis also an important provider in dialysis treatment. B. Braun Avitumoperates a global network of over 200 dialysis centers, in whichwell-trained doctors and nurses are helping over 10,000 chronicdialysis patients in Europe, Asia, and South Africa to achieve abetter quality of life using the latest medical technology.

Expertise in production and developmentDialyzers are essential in hemodialysis. For over 10 years, B. BraunAvitum has carried out its own development and production inGermany in the area of dialyzers. Diacap dialyzers have been successfully used in dialysis centers throughout the world for manyyears and they offer consistent performance for achieving goodquality dialysis. The modern fully-synthetic polysulfone dialyzersdemonstrate excellent biocompatibility and good performance.B. Braun Avitum places great value on its ongoing development ofmembrane materials and dialyzers as well as large-scale industrialproduction, so that patients can derive even greater benefit fromdialysis therapy. The key to future success is continuous researchand development.The manufacturing process focuses on product safety and quality.All B. Braun Avitum dialysers satisfy the highest quality standards.The dialysers are produced on the latest production lines. Automated test processes that far exceed industry standards ensureconsistently high product quality.Dialyzers by B. Braun Avitum are used every day throughout theworld, contributing toward the quality of life of thousands ofdialysis patients.B. Braun AvitumA comprehensive system supplierB. Braun Avitum has been a leading provider of dialysis careproducts for more than 30 years. The product range includesdialysis machines and dialysis consumables for chronic andacute dialysis.B. Braun Avitum does much more than simply manufacturehigh quality dialysis machines, dialyzers and disposables. Thecompany offers an integrated system which is composed ofperfectly harmonized components. These include a wide rangeof therapy options and software solutions for an optimal dialysisand economic treatment processes. Technical services, planning,installation, training and process consulting complement ourproduct offerings. Customers profit from the expertise of anall-round system supplier with comprehensive knowledge andexperience of every aspect of the dialysis situation – from researchthrough manufacturing to therapy.duct solutionsProDialysismachinesDisinfectionB. etersSolutions andconcentratesWatertreatmentsystemsA/Vsystems

High Flux -the modern form of therapy in dialysisHigh flux has benefits in high risk patientsn Middle molecules are the focus of scientific interestn Current studies show a positive effect from high flux dialysis,especially in high risk patientsn Survival rates can be increased by the use of high fluxdialyzersn β2-microglobulin is a marker protein for middle moleculeclearanceMPO study results1n Significant survival benefit from treatment withhigh flux dialyzersn Use of high flux dialyzers in patients with a serum albuminlevel of 4 g/dl was able to significantly reduce the relativemortality risk by 37%n Mortality was also significantly reduced in diabetes patientsn β2m elimination over the course of treatment in the high fluxgroup was significantly greater than in the low flux groupClinical evaluationn Patients who are elderly, suffering from malnutrition or whohave several accompanying illnesses can benefit from highflux dialysisn Chronic inflammation can be reducedn Side effects such as dialysis-associated amyloidosis with theclinical symptoms of carpal tunnel syndrome or vascularchanges (destructive arthopathy) can be prevented by higherβ2m eliminationAddition to EBPG2n Incorporation of the MPO study into the European BestPractice Guidelines (EBPG)n European Renal Best Practice advisory board stronglyrecommends the use of synthetic high flux membranesfor all dialysis patients1.0Survival probability in patients0.8high flux0.637% reduction in the relative mortality risk of patientswith malnutrition under high flux dialysis0.4low flux0.20.012243648607284MonthFig.: Kaplan-Meier survival curve in patients with serum albumin 4 g/dl in the low flux and the high fluxgroup (Log-rank Test P 0.032)ConclusionPatient outcome can be improved.All patients should be treated with modern high flux dialyzers!4

References:1 Locatelli F et al.: Effect of Membrane Permeabilityon Survival of Haemodialysis Patients, J Am SocNephrol 20: 645-654 (2009)2 Tattershall J et al.: High-flux or low-flux dialysis:a position statement following publication of theMembrane Permeability Outcome study, Nephrol.Dial. Transplant (2009)5

Diacap HIPSPerformance confirmed by studiesDiacap HIPS dialyzers offer consistently reliable and efficient dialysis3Study design55 patients, duration: 8 month, surface area: 1.8 m2, dialysis mode: HDFX 80Diacap HIPS 18Delivered dialysis dose (eKt/V)No changes in eKt/V after the switch. Patient levels stayedconstantly good. The minimal eKt/V level should be above 1.2,which corresponds to a spKt/V of 1.4.eKt/V1.61.2Switch0.8Month1234FX 805678Diacap HIPS 18Course of phosphateDiacap shows constant elimination of phosphate over the studyperiod. No significant changes after the switch from the FXdialyzer to Diacap.mg/dl64.5Switch3Month1234FX 805678Diacap HIPS 18Heparin usageHeparin dosage was stable over the study period. Important alsoafter the switch: the amount of heparin is constant. No significantchanges occurred.IU/kg BW6050Switch40Month12345678References: 3 Bonilla B et al.: Nefrovall, Spain, 2008; Measurement conditions: patients 55, duration 8 months, dialysis mode: HD, treatment time: 234 min, mean QB 308 ml/min, mean QD 550 ml/minConclusionStudies confirm that the efficiency and quality ofdialysis remains constant and comparable over along treatment period with Diacap

Diacap HiFloFor efficient high flux dialysis and hemodiafiltrationStudy confirms excellent performance of Diacap HiFlo4Study design15 Patients, duration: 2 weeks, dialysis mode: HDFMiddle molecule removal and albumin1.61.581.41.3β2m reduction rate (%)eKt/V1.5801.273.964042020HiFlo 23Diacap HiFlo achieved an average eKt/V of 1.58 during the study.The minimal eKt/V level should be above 1.2, which corresponds toa spKt/V of 1.4.6080.9HiFlo 23Albumin loss (g)Delivered dialysis dose (eKt/V)0Clinical studies show that Diacap HiFlo demonstrates a very goodreduction rate of middle molecules (β2m), with especially lowalbumin loss.References: 4 Pedrini L et al.: Efficiency of post-dilution hemodiafiltration with a high-flux-polysulfone dialyzer, Int J Artif Organs 34 (5): 397-404 (2011); Measurement conditions: patients 15, duration 2 weeks, dialysismode: HDF, treatment time: 224 min, mean QB 372 ml/min, mean QD 554 ml/min;ConclusionIn addition to excellent small molecule clearance, Diacap HiFlodemonstrates a very good balance between high β2m-eliminationand minimal albumin loss, as the study results verify

Constant performance,resulting in consistent quality of dialysisReliabilitynConstant goodperformance(low molecular clearance, Kt/V)nDelivery on timeevery timeSafetynnProven polysulfonemembraneGamma sterilizationReliability Constant good performance in small and middle moleculeclearance especially urea, phosphate, creatinine, andβ2-microglobulin Good albumin retention (HiFlo) in dialysis patients withmalnutrition Full product portfolioSafety Proven polysulfone membrane for optimal endotoxin retention For years, gamma sterilization has been known to be a safe,well-tolerated, and tried and tested form of sterilization thatdoes not leave any residues in the final product Detachable extra label for medical record keeping and 100%product traceabilityQuality Over 10 years’ know-how in membrane development andproduction. All dialyzers are manufactured using the latestproduction equipment and ensure consistently high productqualityDiacapReliable and safe dialyzer of highquality from B. Braun, a trustedpartnerQualitynnMade in GermanyOver 10 years ofmembrane &production expertiseTrustnExcellent service &support

Diacap Product FamilyVariety for efficient treatment qualityDiacap high flux dialyzersHIPS 10HIPS 12HIPS 15HIPS 18HIPS 20HiFlo 18HiFlo 23Surface (m²)1.01.21.51.82.01.82.3Ultrafiltration coefficient (ml/h/mmHg)34425055587892Priming volume bloodside (ml)586890110121100120Wall thickness/internal diameter (µm)40/200Units per boxArticle number38/19520720 3622720 3630720 3649720 3657720 3665720 3673720 3681Diacap low flux dialyzersLOPS 10LOPS 12LOPS 15LOPS 18LOPS 20Surface (m²)1.01.21.51.82.0Ultrafiltration coefficient (ml/h/mmHg)6.87.99.812.313.7Priming volume bloodside (ml)586890110121720 3550720 3568Wall thickness/internal diameter (µm)40/200Units per boxArticle number20720 3525720 3533ConclusionThe Diacap family offers an extensive portfoliofor all therapy requirements. Dialysis patientscan be efficiently treated with LOPS, HIPS,and HiFlo720 3541

B. Braun Avitum AG Schwarzenberger Weg 73-79 34212 Melsungen GermanyTel. 49 5661 71-2624 Fax 49 5661 75-2624 dialysis@bbraun.com www.bbraun-dialysis.com7081061A

High flux has benefits in high risk patients n Middle molecules are the focus of scientific interest n Current studies show a positive effect from high flux dialysis, especially in high risk patients n Survival rates can be increased by the use of high flux dialyzers n β2-microglobulin is a marker protein for middle molecule clearance MPO study results1 n Significant survival benefit from .