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. Fresenius Medical Care is currently working on 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 machine. We tested the VND intensively in 2010 and want to integrate it into the monitor of our 4008 and 5008 series dialysis machines this year. Although the VND cannot eliminate the risk of blood loss completely, we are convinced that, with this new system, we have developed a particularly reliable technology which to date has no comparable available alternative in the dialysis market.

Fresenius Medical Care has been working for some years within a team of experts on the development of a wearable artificial kidney – a dialyzer system that is small and light enough to be worn on the patient’s body and that replicates the natural functioning of the kidney particularly well by operating continuously.

To be wearable, the system must be able to function with substantially less dialysate than the standard methods of peritoneal dialysis and hemodialysis. To achieve this, the amount of dialysate has to be reduced from currently about 175 to 360 liters per week (depending on the method) to about 150 to 500 milliliters which circulate in the device and are repeatedly cleansed and recycled. The dialysate can be cleansed with the help of sorbents – substances that effectively bind the toxins and waste substances in the dialysate (adsorption). However, urea is a critical exception. To effectively remove urea from the used dialysate as well, Fresenius Medical Care, building on its many decades of experience in the field of polysulphone membranes, has developed a novel hollow fiber membrane. It consists of a double-layer which, through its structure and composition, actively controls the passage of substances. A functional coating enables the urea to pass from the dialysate but retains the vital electrolyte. The urea is chemically decomposed by an enzyme in the outer part of the hollow fibers. Sorbents bind the ammonium that is released and prevent any toxic ammonium residues passing back into the dialysate. The basis for the new, multi-layer membrane is an innovative silicon-based micromechanical technology. This technology serves to produce microscopically tiny spinnerets required to process various membrane materials, including polysulphone, at several levels simultaneously. We filed a number of patent applications for the complex structure of the spinnerets. The double-layer urea membrane, which we now want to further optimize for use in a wearable artificial kidney, is a first practical result of the new spinning process. However, the technology is essentially of considerable interest for all sorbent-based dialysis systems, in which the dialysate needs to be recycled, thus enabling more patients to be treated flexibly outside the clinic.

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 is our new 2008T hemodialysis machine for the U.S. market. After approval from the FDA (U.S. Food and Drug Administration) we launched the machine in November 2010 on the occasion of the ASN (the American Society of Nephrology Conference), the most important conference of its kind in the United States. It is the first hemodialysis machine approved for the U.S. market to use an integrated software platform for entering and administering clinical treatment data directly from the patient’s bedside. In view of the new bundled rate reimbursement system in place in the United States since January 2011, the new module should support doctors and clinic staff in compiling the data which the authorities require for accounting the service efficiently and promptly. It should also help to simplify day-to-day working routines and further improve clinical data and quality management at the clinics. We are also currently testing an integrated infusion pump for intravenously administered iron preparations which we have specially developed for the 2008T and which has already been approved by the FDA. This is designed to make the administration of the iron preparation and its exact dosage easier for clinic staff and thus further increase safety for the patient. We want to launch the new module already in 2011.

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