PROJECT PLAN OUTLINE Sample Clauses

PROJECT PLAN OUTLINE. Research and experimental work will be carried out by the Department of Vascular Surgery at The Royal Free Hospital Medical School. CardiTech will manufacture polycarbonate urethane grafts for the project at its facilities near Xxxxxxx. The present polycarbonate graft which has been developed for vascular access by CardioTech will be studied in vitro by the academic partner to ascertain its suitability to meet the more demanding requirements in peripheral vascular bypass grafting. The results from evaluation will be combined with study results and other development information from CardioTech International Ltd to allow an application to be made to an Ethics Committee leading to a pilot clinical investigation with the objective of determining the short term clinical performance of the grafts, providing the clinical information required to comply with the essential requirements of the EU Medical Devices Directive. The clinical investigation will commence no later than May 1998. In parallel to this work evaluation of alternative adjunctive technologies will be instigated. In particular endothelial cell seeding of the ChronoFlex will be undertaken to reduce the thrombogenicity of the graft surface. Grafts will go through a selection process of physical and mechanical testing by CardioTech (ISO/DS 7198 Tubular Vascular Grafts) and in vitro and in vivo research at the laboratories of the academic partner leading to clinical evaluation. The project will consist of a series of tasks which are described in outline as follows: -------------------------------------------------------------------------------- PROJECT 1 IN VITRO INVESTIGATION OF POLYCARBONATE URETHANE GRAFT FOR TASKS 1.1 - 1.4 LOWER LIMB ARTERIAL BYPASS -------------------------------------------------------------------------------- Objective: Research the compliance and pulsatile flow characteristics Responsible: Royal Free Hospital, dept. of vascular surgery Description of Work: Peripheral arterial bypass grafts have to pass over the knee joint and there is concern for possible kinking of the graft at flexion points. CardioTech will add to the existing access graft an external supporting layer to improve the anti-kinking properties of the graft for peripheral use. The reinforced peripheral graft will be made in both 4 and 5 mm internal diameters to provide a closer match to the natural vessels. Grafts will be manufactured by CTI for evaluation of the compliance characteristics of the polycarbonate ure...
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