Project: New generation fistula catheter technology for haemodialysis

_x000D_Dialysis_x000D__x000D__x000D_Dialysis is the treatment which is done when the kidneys malfunction. The method of the treatment is that you in a closed system lead the blood of the patient through a dialysis system - a filter. After the filtration the purified blood re-leads to the patient. To be able to perform this treatment you need access to the veins of the patient for connection of the dialysis machine with the patient. A person, who has disordering kidneys and needs dialysis treatment, can be treated in three different ways:_x000D__x000D_• Blood dialysis – haemodialysis. The method we use._x000D_• Bag dialysis- peritoneal dialysis. This treatment is performed by the patient himself by using the _x000D_ peritoneum as dialysis membrane._x000D_• Transplantation. The patient receives a new kidney._x000D__x000D__x000D_Background_x000D__x000D_In the world there are about 2 millions persons who have malfunctioning kidneys. About 80 % of these persons receive blood dialysis treatment through the haemodialysis method and most of the others are treated with peritoneal dialysis method. In this project we are only working with the ´haemodialysis´ method. Therefore we call in the following ´ haemodialysis method´ for dialysis._x000D__x000D_Each patient performs as an average three treatments a week. This gives about 150 treatments per patient and year. In the world this means about 240 million treatments a year. As a comparison in Sweden there are performed about 400 000 dialysis treatments a year._x000D__x000D_With the haemodialysis method you use steel needles and a fistula to get access to the patient’s blood vessels. In 70% of the cases a fistula is used, made by a surgically connection of two blood vessels. As the treatment takes 4 – 5 hours it is very difficult for the patient not to move the needle etc. The needle is very sharp and causes very often damages on the fistula and the patient´s vessels. The major problem is the cost for multiple operations due to a short fistula life length – the dialysis needle damages the fistula. Creation of a new fistula takes about 8 weeks of maturing, which results in unnecessary pain for the patient and high cost for the society (fistula costs 16 000 Euro/patient/year). At each treatment you need two fistula catheters. _x000D__x000D__x000D__x000D_Objective of the project_x000D__x000D_The objective of this project is to develop a new highly flexible catheter which _x000D_• decreases the risk of damages on the fistula when introduced and when the treatment is performed_x000D_• increases the flow rate and thereby decreases the treatment time_x000D__x000D_This new technique will reduce the vascular damage problems and complications, reduce the costs and the total time of dialysis and thereby improve the quality of life for the treated persons. For the SME Ps the objective is to develop a low-cost, highly flexible catheter with increased flow rate through a new technique, design and material combinations. This new AV (arteriovenous) access device will give the SME Ps considerably improved competitiveness and also open possibilities for other SMEs who in their businesses have similar problems. _x000D__x000D_The Ps have worked with this development 3 - 4 years but still there are some technical problems hindering the development. In this project we will work with solving these problems so we can start production and marketing of the new fistula catheter in large quantities. _x000D__x000D__x000D__x000D__x000D_Market application _x000D__x000D__x000D_The result will be a new low-cost, highly flexible catheter with increased flow rates for hospitals and dialysis clinics. The SME Ps will exploit the results by selling the systems in Europe and the USA. SME Ps in other countries will be able to buy production/sales licences. Exploitation and dissemination of result will start at Medica in Düsseldorf 2011/12. The market for haemodialysis is very large (about 350 - 400 million catheters) and is increasing with the aging population. _x000D__x000D_Through this RTD project the competitiveness of the SME Ps will be much improved. They will get an ´own´ product with a very large market potential and with large possibilities for their companies to grow considerably. The success of the project will also create a large number of new employments at both Medcom - Carbonex and their suppliers - preferably local SMEs._x000D__x000D__x000D__x000D_General description of the consortium_x000D__x000D_SME RTD performing Ps_x000D_- Nordic Medcom AB , Borås, Sweden. Leading P_x000D_ acronym Medcom_x000D_ Produces, develops and markets haemodialysis systems for the Scandinavian markets._x000D__x000D_- OY Carbonex AB, Espoo, Finland_x000D_ acronym Carbonex _x000D_ Distributes and markets haemodialysis systems for the Finnish market._x000D__x000D_RTD P_x000D_- Stiftelsen Chalmers Industriteknik, Göteborg, Sweden_x000D_ acronym CIT_x000D_ CIT has a broad, cross disciplinary spectra of state-of-the-art competence within science and technology, including medical devices._x000D_

Acronym Fistula Catheter (Reference Number: 4775)
Duration 01/09/2009 - 28/02/2012
Project Topic The overall objective is to develop a flexible, low-cost fistula catheter based on novel technology in order to improve the dialysis treatment for patients and reduce the risks connected with dialysis.
Project Results
(after finalisation)
We have a product!!
Network Eurostars
Call Eurostars Cut-Off 2

Project partner

Number Name Role Country
3 Nordic Medcom AB Coordinator Sweden
3 Oy Carbonex AB Partner Finland
3 Stiftelsen Chalmers Industriteknik Partner Sweden