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Fresenius Medical Care

The complex interactions and side effects that lead to kidney failure are better explored today than ever before. Parallel with the medical insights, technological advances also improve the possibilities for treating patients. For the R & D activities at Fresenius Medical Care, this means that our aim is to translate new insights into novel or improved developments and bring them to market as quickly as possible, and thus make an important contribution toward rendering the treatment of patients increasingly comfortable, safe, and individualized.

With advancing age, dialysis patients become more prone to side effects such as severe heart and vascular diseases. Such ailments typically occur when the body perpetually suffers from overhydration as a result of kidney failure. Side effects are therefore a growing focus in our R & D activities – in the form of diagnostic and therapy systems surpassing general dialysis.

Home dialysis treatment methods – peritoneal dialysis, home hemodialysis, and, in the long term, a wearable artificial kidney – and related technologies and products are another focus of our R & D. Home dialysis not only means that patients who are suitable for such treatment can organize their day-to-day life more freely. It also increasingly relieves the limited capacities of the dialysis clinics and makes dialysis possible in the first place for people living in areas with a weak health care infrastructure.

Given rising cost pressure in the health care sector, innovations must also be affordable. High-quality treatment delivers cost efficiency when it minimizes risks and complications and thus avoids additional costs, for instance for hospital treatment. In our R & D we are focusing on products and services that support our customers in providing quality care to patients at affordable cost.

We now describe some of the focuses of our work in more detail:

In our continuous product improvement process, for instance, we are focusing on minimizing the risk of harm to patients as a result of technical faults or human error. A rare but particularly high-risk hazard is blood loss during dialysis – for instance as a result of leaks in the bloodline or dislodgement of the needle connecting the patient’s blood vessel to the bloodline system. Blood loss can then occur directly and cause death within a short time. Therefore Fresenius Medical Care has developed a new safety system based on innovative software: the Venous Needle Disconnect (VND). This is capable of intelligently evaluating extracorporeal pressure signals. It can detect normal disruptions as such and reacts to fine but potentially hazardous pressure irregularities – for instance as a result of the dislodgement of the needle, leakages, or buckled bloodline segments – with an alarm that activates the necessary safety responses on the dialysis device. The VND is an important innovation that makes it easier to recognize blood loss. Nevertheless, the risk of blood loss cannot be completely eliminated with this innovation, but it can be minimized, for example by combining the VND with a wetness detector. We are convinced that this new system offers a particularly reliable technology, for which there are no comparable alternatives in the dialysis market to date.

Since November 2011, these features have been on the market under the name Venous Access Monitoring (VAM) with special software for the hemodialysis therapy system 5008. This software version also includes the interface for connecting a Wetness Detector to the patient’s vascular access. The Wetness Detector is a sensor that reacts to blood escaping at the vascular access. The VAM has proven successful in comprehensive clinical tests encompassing around 40,000 hemodialysis treatments.

We have also made progress in the dialyzer area and launched the FX CorDiax Dialyzer in June 2011. It contains a highperformance Helixone® plus membrane that selectively filters out toxins with a medium molecular size and low molecular weight, such as phosphates, from the blood, thus reducing the risk of cardiovascular diseases. The membrane also ensures that substances beneficial to the patient, such as the essential blood component albumin, are not flushed out at the same time.

A typical consequence of chronic kidney failure is overhydration because the patient’s body is no longer able to naturally excrete surplus fluids. Around a quarter of hemodialysis patients are overhydrated to a critical degree. Overhydration is a problem as it is frequently the cause of cardiovascular diseases. In addition, overhydration can reduce the effectiveness of medication prescribed for diseases associated with kidney failure.

With the new Crit-Line analysis device, changes in fluid levels in hemodialysis patients during treatment can get measured exactly. Crit-Line measures the percentage of red blood corpuscles (hematocrit level) and uses this to determine the percentage change in the volume of blood during dialysis – non-invasively and with laboratory quality results. The results of the analysis are then transferred to the device monitor. Based on these results, the medical staff can adjust the dialysis so that exactly the right amount of fluid is removed from the body. In this way, it is possible to reduce overhydration and its impact on the cardiovascular system as well as high blood pressure without causing undesirable attendant symptoms.

In addition, Crit-Line helps in the treatment of anemia in renal patients. The measured hematocrit values can also be used to adjust the EPO dose so that no additional blood samples need to be taken.

In November 2011, at the ASN Renal Week organized by the American Society for Nephrology (ASN) we introduced a treatment system especially developed for flexible use in home hemodialysis on the U.S. market: the new 2008K@home. It is one of only two devices for home hemodialysis with FDA approval in the entire North American market. With the new 2008K@home, treatment can be individually adapted to the medical requirements of the patients. Physicians have the flexibility of offering patients a treatment schedule that is tailored to their lifestyle. The 2008K@home is especially configured for home use: It takes up less space than comparable machines used in dialysis clinics, for example. In addition, the user interface has been drastically simplified so that patients can operate the machine intuitively: For example, instructions on the screen guide the patient step by step through the set-up and treatment procedure. The 2008K@home also contains a new alarm feature for additional safety: the wetness detector. A signal sounds as soon as a leak at the vascular access occurs during dialysis, which, if it were to go unnoticed, could be fatal. In the current financial year, we are planning to continue working on further optimizing our 2008 series.

Another R & D focus is integrating therapy systems and software solutions. This improves the performance of the dialysis treatment on the one hand, and it’s recording and monitoring on the other, resulting not only in higher treatment quality but also in a more efficient use of human, medical, and financial resources. One example of such a therapy system is our 2008T hemodialysis machine. It is the first approved hemodialysis machine on the U.S. market with an integrated software platform for entering and managing clinical treatment data directly at the treatment couch. The new module is designed to assist physicians and clinic staff in efficiently and promptly recording data and to improve clinical data and quality management. The 2008T can be connected to the various data management systems. Clinic staff benefit from the device as it enables them for the first time to access both dialysis treatment data and data from the medical information system in the treatment room. This data was previously recorded and stored in a variety of sources. Thereby treatment and treatment plans can be directly adjusted individually. In the current financial year, we will continue to work on an infusion pump for administering iron products intravenously as a module for the 2008T. The pump is designed to make it easier for clinic staff to prepare and administer the exact dosage of iron products, thereby further increasing patients’ safety.

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