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Micell has demonstrated the application of supercritical fluid (SCF) based medical device surface modification by coating coronary stents with a drug-eluting polymer matrix. At present, drug-eluting stents have been shown in clinical trials to reduce early stage restenosis. Longer term results related to reocclusion, however, have been less robust. Inherent process control limitations of current solvent-based methods, as well as challenges associated with maintaining structural and morphological integrity of the therapeutic agents deposited during the coating process have been significant challenges to date. Improvements in coating technology (uniformity, conformity, control of drug morphology), along with use of potentially other classes of active therapeutic agents may help to address these issues.
Micell's CritiCoat™ and CritiFlo™ supercritical fluid based technology platform creates an opportunity to deliver the next generation of drug-eluting stents that can provide control over drug morphology and may allow manufacturing processes to apply discrete and independent therapies within a single, multi-therapy coating. The figures to the right illustrate how Micell has used the CritCoat™ and CritiFlo™ methods to create a drug-eluting coating on a state of the art metal stent. Maintaining the morphology of the drug(s) is achieved by avoiding the need to dissolve the drug in a liquid solvent, as is necessary under conventional methods. The polymer nanoparticles created by Micell's CritiCoat™ method are then sintered using the CritiFlo™ process, with no impact to the morphology of the drug component. A critical advantage realized by maintaining the morphology of certain drugs is that it provides the potential for increasing the stability of the compound.
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