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Prsentation of Research Program: Development and study of innovative endovascular balloon system for the local administration of innovative drug (ClEver Balloon).

Development and study of innovative endovascular balloon system for the local administration of innovative drug (ClEver Balloon).

The project is co‐financed by the European Union and Greek national funds through the Operational Program Competitiveness, Entrepreneurship and Innovation, under the call RESEARCH – CREATE - INNOVATE (project code:Τ2EDK-03677)

Purpose of the project ClEver Balloon is the development of a new medical device for the treatment of arterial disease, an endovascular drug coated balloon catheter (DCB). The product is expected to achieve effective local administration of everolimus, a known but innovative for this specific application drug, with the use of an innovative “CLEVER” drug release system that has been patented by the project partners with two international patents. Preliminary results have shown that the developed technologies overcome the currently existing difficulty for effective and fast delivery of everolimus in the short time of expansion of an endovascular balloon, succeeding for the first time the use in balloons of this drug that has been proved to be most effective in treatment of restenosis. The project includes development of prototypes, in vivo, in vitro and in silico studies in order to secure the successful development of a novel drug eluting medical device that will exceed by far the existing internationally state of the art. The effect of the combination of the components of the new product will be studied in vitro on smooth muscle cells and the molecular mechanism of their action will be examined. The new DCB will also be studied in vivo in experimental models in order to examine the safety and effectiveness. The results of the in vivo studies will be used for the development of in silico platform involving three-dimensional simulation of the arterial wall and modeling of the balloon behavior during expansion in order to model the drug release with further purpose the prediction of the behavior of the product and for minimizing in the future the need for animal studies according to the latest directives.

Partners of the project are the following: University of Thessaly, University of Ioannina, University of Patras, Biomedical Research Foundation of the Academy of Athens, Rontis Hellas SA, Simtec SA.

Main purpose of the project is the development and study of a novel, safe and effective drug coated balloon that will exceed current state of the art, with a potential to become a first choice therapy for specific cases of arterial disease and its complications. The innovations of the project include the use of a novel patented effective drug delivery system for a new effective drug and the development and use of simulation software and in silico platform in order to minimize the need for in vivo experiments.