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New technology for haemodialysis

Final Report Summary - FISTULA CATHETER (New technology for haemodialysis)

Project partners have developed a soft and flexible catheter that is to be inserted into a patient and stay there during dialyses without damaging the fistula. The main stated objective i.e. to reduce damages on the fistula caused by the steel needle, is met. This will enable the patient to move more freely during treatment without damaging the fistula and this will increase the life of the fistula.

During the research and development phase we have at several occasions, together with our partners, showed our progress with the new catheter to nurses in different countries. This was done to ensure that our product and the design of our product meet their requirements and expectations. This varies slightly depending on the country. We have made a great amount of work to ensure that the nurses are 100 % satisfied with the product. Without their acceptance the products may not be used in the market so it is a very important foundation for the success of the product. This has taken a lot of time and effort from us and our partners. However, the input and comments along the way really improved the design of the product and the product is now accepted. Today we have costumers waiting for the final product. One of the main problems with a-v fistulas can now be greatly reduced. By using our product the fistulas will survive for a longer time giving the patient a better comfort and quality of life.

The flow of the new fistula catheter design improves the blood flow by 25 percent and fulfils the objective to get a better flow, compared to the competitors. The inner lumen has been designed to give an improved and optimised flow. The design also provides smooth transitions between the different components in the catheter. Results from flow studies were combined with production to ensure that the product will be possible to manufacture according to the desired design.

The result is a new type of catheter with a soft shape catheter, i.e. the metallic needle is withdrawn after punctuation leaving the soft catheter in the blood during treatment. The effect of the shape catheter is that is increases the surveillance of the fistula, i.e. reducing the risk for damaging the fistula. It also improves the freedom of movement for the patient during haemodialysis as well as the working conditions for the health care workers. Also other parts have been developed. For instance, the design of the inner lumen has been improved. This resulted in a product with enhanced flow properties enabling shorter time for dialysis. This is also appreciated by patients with chronic kidney deceases as they need dialysis three times a week.

In addition with our R&D work we have discussed the design and ergonomic features wanted by health care workers such as nurses and doctors working with haemodialysis. Also health care workers in other European countries have been involved. In these cases the discussion was held by the small- and medium-sized enterprise (SME) partners. These discussions led us to make a catheter with a more ergonomic and user-friendly design. For instance, the wings are a direct result of this. Our concept improves the over all procedure of performing dialysis.

Expected end results are that this project will continue until the final version is manufactured in full scale production and available at the market. This project will hence result in a product that will be used in many countries all over the world with improved conditions for the dialysis patients. We will not rush into marketing. The most important thing is to ensure the reliability of the product and its manufacturing process. Also the products must obtain CE branding and the clinical studies will be finalised with good outcome. The device will reduce the costs and the total time of dialysis and thereby improving the quality of life for a number of patients.

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