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Our Product Business

Our Product Business

We use our many years of experience and extensive technological expertise to continuously enhance our products with the aim of constantly optimizing the succ ess of dialysis treatment, minimizing the risk factors for cardiovascular diseases and making life easier for dialysis patients. Our main considerations in developing and manufacturing our dialysis products are their quality and safety.

Products for hemodialysis

Hemodialysis (HD) is the most common type of renal replacement therapy. In dialysis centers, the patient’s blood is filtered outside the body in a so-called dialyzer. In this process, toxins and excess water are removed, while blood cells and important proteins remain in the blood. Blood circulation is monitored and controlled by a dialysis machine during treatment. Fresenius Medical Care offers a comprehensive range of products for HD, including HD machines and modular machine components, dialyzers, bloodline systems, HD solutions and concentrates, needles, water treatment systems, data processing and analysis systems, and dialysis chairs.

Dialysis machines

Computer-driven dialysis machines perform key tasks during hemodialysis: They pump blood from the patient’s body through a bloodline system into the dialyzer. A dialysis fluid absorbs the toxins and excess water filtered out of the blood and transports them out of the body. The dialysis fluid is fed into the dialyzer via a separate cycle. The device also adds an anti-coagulation drug to the blood. In addition, the machine is equipped with various automatic monitoring and control functions that ensure safe and efficient dialysis treatment. The modular design of our hemodialysis machines allows treatment to be tailored to patients’ individual needs and makes it easier for us to constantly enhance our devices and modules. For further information, see the “Research and development” chapter.

With its 2008T, 4008S classic and 5008 series dialysis machines, Fresenius Medical Care is the clear market leader. We sold 42,350 dialysis machines worldwide in 2012 (2011: 40,150). This means that more than one in two systems sold are produced by Fresenius Medical Care.

The 5008 therapy system features an extremely intuitive user interface. Its touchscreen makes the device easy and safe for doctors and nursing staff to use. In addition, this dialysis machine allows for ONLINE hemodiafiltration (HDF) – see Glossary – as a standard feature. One of the advantages of this type of treatment is that it controls blood pressure and anemia more effectively and therefore has a positive impact on risk factors for cardiovascular diseases. By upgrading the device to the 5008 Cordiax, launched in the reporting year, Fresenius Medical Care has combined proven functions with totally new or improved applications. For example, the new 5008 Cordiax includes a special monitoring system that reacts promptly if the venous needle comes loose.

The 4008S classic system boasts impressive standard features and delivers very high treatment quality as well as reliability and safety at a low price. This gives even more dialysis patients easier access to high-quality dialysis treatment, for instance in regions with a poor infrastructure.

The 2008T dialysis machine for the North American market combines state-of-the-art treatment technology with the “Fresenius Clinical Data Exchange (CDX)” system, a software to record and exchange clinical data. This gives nursing staff direct on-site access to dialysis treatment data and all other clinical data that would otherwise be recorded and stored in different sources. As a result, this integrated treatment system simplifies routines as well as billing under the bundled reimbursement system in force in the U.S.

Dialyzers

The dialyzer assumes key functions of the kidney. In a plastic tube approximately 30 centimeters long, the patient’s blood flows through up to 20,000 ultra-thin fibers. These extremely high-performance fibers are made of Fresenius Polysulfone, a special plastic characterized by exceptional cleansing properties and blood compatibility. This material is the result of our pioneering work in the development and production of dialyzers, and sets new standards in dialysis. The Helixone membrane, also developed and produced by Fresenius Medical Care, is an enhanced form of Polysulfone.

Dialyzers are generally used only once. Fresenius Medical Care also leads the field in this area. With our FX and FX CorDiax dialyzer series as well as its Optiflux series in North America, we provide a wide range of dialyzers. Thereby we meet the specific requirements of various therapy methods and patients’ individual needs. Fresenius Medical Care has also developed dialyzers with a low blood priming volume specifically for treating children with dialysis.

Fresenius Medical Care sold about 100 M dialyzers in 2012 (2011: 93 M). The Company thus accounts for almost half of the global market of this product group.

From manufacturing membranes to packaging – Fresenius Medical Care carries out the entire production process for dialyzers under one roof. This enables us to observe high quality standards.

Analysis systems

Overhydration is a widespread problem among dialysis patients and a significant cause of cardiovascular diseases. In addition, it can reduce the effectiveness of medication prescribed for illnesses associated with kidney failure. An optimum fluid balance is therefore a key challenge in treating patients with chronic kidney failure.

The patient’s individual fluid status can be measured extremely well with the Fresenius Medical Care Body Composition Monitor analysis system. The results can also be used to track and better understand the correlation between overhydration and blood pressure in each patient.

The Crit-Line analysis device developed for the North American market also measures changes in the fluid balance of hemodialysis patients during treatment. This makes it possible to identify risk patients who are severely overhydrated but otherwise show no clinical symptoms. Crit-Line is also used to support the treatment of anemia in kidney patients.

Products for peritoneal dialysis

In peritoneal dialysis the peritoneum is a natural filter. It has properties similar to the membranes used in the dialyzer, allowing certain substances to permeate its pores while keeping others back. Dialysis via the peritoneum is called peritoneal dialysis (PD). PD is carried out by patients themselves at home or on the move, for example at work. We offer PD systems and solutions for continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD). Both therapies are supported by our patient management software.

Continuous ambulatory peritoneal dialysis

In continuous ambulatory peritoneal dialysis, dialysis solution is fed from a bag through a catheter into the patient’s abdominal cavity, where it is flushed through the peritoneum. This process is carried out three to five times a day. After four to five hours, the patient drains the dialysis solution – now mixed with metabolic products – into an empty bag and replaces it with new solution. This ensures that the blood is continuously cleansed.

Stay.safe is a system provided by Fresenius Medical Care for continuous ambulatory peritoneal dialysis. It consists of a bag filled with fresh dialysis solution, an empty bag for the used solution, a system of tubes, and DISC, a central control switch specially developed by Fresenius Medical Care. Thanks to DISC technology, all treatment steps can be performed safely and easily in a defined sequence, virtually eliminating operating errors. In addition, the DISC features a special valve system that prevents bacteria from entering the catheter and causing an infection in the peritoneum. All stay.safe components are made of Biofine, an environmentally friendly plastic developed by Fresenius Medical Care comprising only carbon and hydrogen. Products made of Biofine can either be recycled or disposed of in an environmentally friendly way. The PD-Paed System is a product combination that is specifically approved for babies and small children with a body weight of up to 10 kg. It is suitable for treating chronic and acute kidney failure and also enables treatment in an incubator.

Automated peritoneal dialysis

Automated peritoneal dialysis (APD) is mostly carried out at night. A special device called a cycler takes over the exchange of dialysis fluid. In the evening, the patient connects up with the cycler, which then automatically replaces the dialysate after just a short time in the abdominal cavity several times during the night.

Fresenius Medical Care offers modern cyclers for APD such as sleep.safe and the Liberty Cycler specifically for the North American market. They are simple and safe to operate thanks to user-friendly software, easy to carry and allow patients to sleep comfortably during overnight treatment. In the cycler, a hydraulic pump controlled by several pressure sensors performs the fluid exchange. A microprocessor monitors the entire treatment process, and the bags are automatically connected by means of barcode recognition. An integrated heater warms up the dialysis fluid before it is fed into the abdomen. A special version of the sleep.safe is also available for treating children.

Patient management software

We offer various patient management programs in our regions that support both CAPD and APD treatment. They include PatientOnLine, IQsystem, Pack-PD, and FITTesse. These programs help medical staff to tailor dialysis treatment to the patient’s individual needs.

Fresenius Medical Care also produces and sells a host of other products essential to peritoneal dialysis such as PD catheters, disinfectant, or heating plates for heating the PD fluid to body temperature safely and conveniently.

Products for further home therapies

Home hemodialysis (home HD) is an alternative to dialysis in a clinic. In this form of therapy, patients perform their own dialysis treatment at home, possibly with the assistance of a partner or trained personnel. To do this, patients must be trained at a training center.

Fresenius Medical Care’s home hemodialysis products are easy to use and extremely safe. In addition, patients can be connected to the dialysis center from home via a data line to ensure even greater safety. Fresenius Medical Care also supports home HD patients with comprehensive, easy-to-understand training and special services.

Our home HD therapy systems – the 2008K@home for the North American market and the 5008S with a special home HD package – are specifically geared to the requirements of this form of treatment. The package includes a remote control, an integrated blood pressure monitor, and user-friendly software, among other things.

Products for acute dialysis

Continuous renal replacement therapy is used as part of routine clinical practice to treat acute kidney failure in critically ill patients.

Fresenius Medical Care has developed multiFiltrate, a therapy system that can be used for a wide variety of continuous treatment methods. Special therapy options are also available for children’s intensive-care wards.

To prevent blood coagulation during dialysis treatment, heparin is generally administered to patients. Fresenius Medical Care was the first company to develop a system for continuous renal replacement therapy that uses citrate as an anticoagulant with the multiFiltrate Ci-Ca. In contrast to heparin, citrate only prevents coagulation in the blood circulation outside the body. This helps patients in particular with acute bleeding or a susceptibility to bleeding, for example as a result of an injury or after operations.

Products for other blood cleansing procedures

Extracorporeal blood cleansing is not only used to treat chronic kidney failure, but also to support the liver function on a temporary basis. Excess blood fats or pathogenic antibodies can also be removed in this way.

Liver support therapy

The liver performs numerous vital functions in the body. If it cannot fulfill them adequately due to illness, harmful substances quickly build up in the patient’s blood. This can lead to life-threatening symptoms and, in extreme cases, even make a liver transplant necessary. To bridge the gap until the transplant or to prevent one altogether, fast and effective treatment is required.

Fresenius Medical Care’s Prometheus therapy system combines hemodialysis treatment with an adsorptive method, thus temporarily relieving the liver.

Therapeutic apheresis

Therapeutic apheresis is a medical process whereby specific pathogenic components are removed from the blood or plasma outside the body. It is mainly used in patients who can no longer be treated successfully with medication.

The therapeutic removal of specific blood fats (lipoproteins) is called lipid apheresis. DALI and MONET are two effective and gentle therapy methods developed by Fresenius Medical Care for lipid apheresis. Treatment usually lasts one to two hours. One treatment per week is sufficient for most patients.

Immunoapheresis is a therapy option for removing pathogenic antibodies. Immunosorba and Globaffin are two different sorbents offered by Fresenius Medical Care for immunoapheresis. During treatment, plasma is separated from the blood and fed through one of the two adsorbers. This binds the antibodies so that they accumulate in the adsorber and are removed from the plasma.

Dialysis drugs

Although dialysis assumes many key functions of the kidney, it cannot replace all of them. For this reason, patients with chronic kidney disease must also take drugs to keep the body’s mineral levels balanced and prevent anemia. Fresenius Medical Care produces and sells selected preparations for treating patients with chronic kidney disease.

Healthy kidneys produce the hormone erythropoietin (EPO), which stimulates the formation of red blood cells. Insufficient levels of EPO can result in anemia. Frequent consequences are fatigue and an increased risk of cardiovascular diseases. Because iron is also essential for the formation of red blood cells, an iron supplement is also administered to many dialysis patients in addition to EPO.

Phosphate is a mineral that contributes to bone, tissue and muscle formation. However, excessive phosphate levels can cause hardening of the arteries and damage the vascular muscles. In healthy people, excess phosphate is excreted via the kidneys. In people with chronic kidney disease, however, it remains in the blood. Dialysis patients therefore have to take phosphate binders.

If the calcium level in the blood is too low, vitamin D ensures that the body absorbs more calcium from food. Insufficient quantities of vitamin D often lead to calcium deficiency. In healthy people, the kidney produces vitamin D. Dialysis patients can counter a deficiency by taking vitamin D supplements.

In hemodialysis, the blood must not clot outside the body. Therefore, an anticoagulant such as heparin or citrate is added to it via the dialysis machine.

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