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

Increasing evidence is demonstrating that next generation biodegradable coronary stents are
outperforming traditional permanently implanted drug eluting stents. Only two biodegradable
stents are approved for sale within the EU, with several more in development.
Manufacturing of polymer stents introduces significant challenges. Biodegradable polymeric
stents do not have the necessary material properties to facilitate crimping onto balloon
catheter, expansion, and to provide radial support to the target vessel. Different approaches
have been developed to improve the material properties, including blow moulding, annealing
and micro braiding.
Arterius and Bradford University have developed the proprietary technique of Die-Drawing to
improve the mechanical properties. Excellent results have been obtained with financial
support 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 sufficient
for preclinical trials, there is now the need for a dedicated novel pre-production prototype die
drawing system capable of producing high quality tubing in a reproducible manner for the
manufacture of clinically approved coronary, peripheral, urology and biliary stents.
The regulatory requirements for medical device manufacture demand rigorous quality
standards, which development of the production system would aim to meet. Key requirements
of the pre-production die drawing rig are to be capable of producing die drawn tubes of high
surface quality and consistent dimensions along the length. The production process will be
simple and allow for accurate control of tube dimensions. Finally, the system should be clean
room compatible - to produce minimal particles and be easily cleanable.
The proposed system will also be clinically applicable to all types of biodegradable stent
applications.