Design, Development and Validation of a Preproduction Prototype Rig for Clinical evaluation of biodegradable stents

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Increasing evidence is demonstrating that next generation biodegradable coronary stents areoutperforming traditional permanently implanted drug eluting stents. Only two biodegradablestents are approved for sale within the EU, with several more in development.Manufacturing of polymer stents introduces significant challenges. Biodegradable polymericstents do not have the necessary material properties to facilitate crimping onto ballooncatheter, expansion, and to provide radial support to the target vessel. Different approacheshave been developed to improve the material properties, including blow moulding, annealingand micro braiding.Arterius and Bradford University have developed the proprietary technique of Die-Drawing toimprove the mechanical properties. Excellent results have been obtained with financialsupport from Innovate UK-SMART Awards for proof of concept research and development,including preclinical assessment.To date, a small-scale R&D die drawing system has been used. Whilst this proved sufficientfor preclinical trials, there is now the need for a dedicated novel pre-production prototype diedrawing system capable of producing high quality tubing in a reproducible manner for themanufacture of clinically approved coronary, peripheral, urology and biliary stents.The regulatory requirements for medical device manufacture demand rigorous qualitystandards, which development of the production system would aim to meet. Key requirementsof the pre-production die drawing rig are to be capable of producing die drawn tubes of highsurface quality and consistent dimensions along the length. The production process will besimple and allow for accurate control of tube dimensions. Finally, the system should be cleanroom compatible - to produce minimal particles and be easily cleanable.The proposed system will also be clinically applicable to all types of biodegradable stentapplications.