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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. Technological advances develop in parallel with medical insights to 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 towards 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. Side effects are therefore a growing focus in our R & D activities – in the form of diagnostic and therapy systems that extend 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 available for people living in areas with a weak health care infrastructure.

An aging population, the spread of chronic illnesses, and the aspiration to offer new or improved technologies in patient care present major financial challenges to health care systems. Fresenius Medical Care therefore focuses on innovations that provide high quality care to patients at affordable cost.

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

To meet the challenges described and achieve the best possible therapeutic performance, we continued to enhance our dialysis products and therapeutic systems in 2012. We particularly focused on further improving clinical results and the quality of life of patients and minimizing cardiovascular risks, while ensuring optimized control of therapy costs and simple, safe handling of our products.

In 2012, we launched the new 5008 CorDiax therapy system in several countries of the segment International. It combines proven and new functions, connecting top-quality therapy and maximum patient safety with simple handling and sustainable use of available resources. This enables us to attain optimum treatment results and further minimize the risks of cardiovascular diseases.

The 5008 CorDiax therapy system is available with the Venous Access Monitor (VAM), among others. The software-based monitoring system VAM detects if there are leaks in the bloodline system or if the fixture of the venous needle that connects the patient’s vascular access with the bloodline system comes loose, which could lead to blood losses during dialysis treatment. VAM reacts with an alarm that activates the necessary safety responses in the dialysis device.

Current data shows that Online-HDF treatment with our 5008 CorDiax therapy system is particularly gentle and efficient if the volume of blood replaced during dialysis is as high as possible. However, adverse side effects can occur if the level is too high. As the maximum replacement volume can be different with every patient and even with every dialysis treatment, we developed the AutoSub plus software for the 5008 CorDiax in the reporting year. It enables optimized, fully automatic regulation of the blood replacement volume individually tailored to the patient.

Children suffering from kidney failure need special care as part of their dialysis treatment. With this in mind, we launched the 5008 CorDiax HD-Paed in 2012. It is the first hemodialysis device in the world to be approved for children with a body weight of ten kilograms or more.

In 2012, we also enhanced our 2008T therapy system for the U.S. market. We supplemented the dialysis device with an infusion pump for intravenously administered iron compounds and tested it at several dialysis centers. Studies have shown that the pump makes it easier for clinic staff to prepare and administer the exact dosage of iron products, thereby also further increasing patient safety. We aim to increase the popularity of the infusion pump on the market as a component of the 2008T in 2013. In addition, we enhanced and reduced the size of our Crit-Line analysis device in such a way that it can be integrated in our 2008T dialysis machine. Crit-Line is a control element for the fluid balance of patients with chronic and acute kidney failure – and therefore also for detecting and treating attendant symptoms. We expect to launch the enhanced analysis device, called CLiC (Crit-Line in a clip) on the North American market in 2013 following approval from the FDA.

One way of treating the rising number of dialysis patients outside of dialysis centers is home hemodialysis. In 2012, with the 2008k@home in the United States and the 5008 S CorDiax home HD in several countries of the segment International, we enhanced two home hemo dialysis machines that individually adapt treatment to patients’ medical needs and daily lives.

The 2008k@home is one of only two devices specifically for home hemodialysis with FDA approval on the entire North American market. We carried out further product optimizations in the reporting year. A new wireless wetness detector is to be launched in 2013. It features a new alarm function, ensuring additional safety. 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.

Previously, our Online-HDF treatment method was restricted to dialysis in clinics. With the 5008 S CorDiax home HD, this therapy method has also been available as standard in home hemodialysis since 2012. Functions such as cable-free remote control, the user interface intuitively designed with patients in mind and the innovative safety functions were specifically developed for the special needs of home hemodialysis patients.

We are already able to provide some patients a greater flexibility in their daily lives with our home hemodialysis systems. With the portable artificial kidney, which we aim to launch on the North American market following approval from the FDA, we have also developed a device that is set to provide even more dialysis patients with even greater independence in future.

The main advantage of the portable artificial kidney is that: it can be quickly and easily dismantled into two portable sections, making transport easy. In addition, it is easy to use, and simple to assemble and take apart without assistance from a technician. As a result of innovative sorbent technology, the portable artificial kidney needs just six liters of potable tap water per hemodialysis treatment. By way of comparison, conventional hemodialysis requires 120 to 200 liters of specially prepared warm water per treatment. Consequently, connection to the main water supply is no longer essential for dialysis treatment with the portable artificial kidney. This makes it extremely resource-efficient, flexible, and usable almost everywhere, offering dialysis patients maximum independence and mobility.

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