The prime objective of this proposal is the completion of a process of research and development into the feasibility of an implantable pump, a liver assist device (ILIAS). ILIAS is designed to be positioned in the human hepatic portal system and to be capable of improving liver function and reducing portal hypertension arising subsequent to cirrhosis of the liver.
The prime objective of this proposal is the completion of a process of research and development into the feasibility of an implantable pump, a liver assist device (ILIAS). ILIAS is designed to be positioned in the human hepatic portal system and to be capable of improving liver function and reducting portal hypertension arising subsequent to cirrhosis of the liver. To carry out the project a European clinical consortium has been evolved with partners 1, 2 and 3, each of whom is a leading practitioner in the field of liver surgery and treatment. The clinical consortium will work closely with a powerful technological group, with partners 4, 5 and 6. In the UK, part of an ongoing ESPRlT project (IMALP), will determine the behaviour of the pump in liver preparations in vitro. These studies will give way to work in the present proposal, initially on normal pigs and, towards the end of the first year, on pigs with cirrhotic livers. During the first year of the present project, in addition to the animal studies, protocols will be developed preparatory to the implantations of ILIAS pumps into at least ten human recipients during the second and third years. The implantations are planned to take place with at least two in each of the UK centres and three in the other participating clinical centres.
The work on pigs and then in man, will be the clinical arm of the project which will be enacted in parallel and in constant interplay with the various technological developments relevant to ILIAS (grouped under the main headings of Pump, Sensors, Signal Transmission and Battery) which are presently being undertaken in the IMALP project. Partners 5 and 6 are those partners in IMALP focussed on the actual pump, interconnection and packaging development. Their role in the present proposal is to provide the pumps for animal testing and the system for human clinical implants, including display and display software for the physician interface and to take the development of IMALP to human implantability. Partner 4 in the present consortium is the IMALP project coordinator and it will be his role to facilitate the interplay between IMALP and ILIAS. The coordinator of the present project is also an active participating partner of the IMALP consortium. ILIAS is seen as the precompetitive stage of research and development of a fully implantable device the sale of which will, in time, contribute to improvement of the competitiveness of Europe in the global markets and thus help to fulfil the prime aim of the Framework Programmes.
Key Words: Portal hypertension, liver cirrhosis, implantable pump. 0204
Funding SchemeCSC - Cost-sharing contracts
NW3 2PF London