Development in iron biodegradable stents: Fe-stent, polymer-coated, and drug eluting stents
Project Status: 8 Project completed
Commencement Date: 01.12.2014
Duration in months: 36 months
Objective
The Project aim. Within the framework of this project it is planned to design electroformed iron biodegradable stents.
Project related studies are aimed at research on biological compatibility and degradation of iron devices in contact with blood under conditions in vitro and in vivo. For prevention of intense biodegradation at the initial stage after implantation the stents will be covered by a polymer film. Before pre-clinical and clinical testing at the hospital, biological experiments will be carried out in laboratory animals in order to obtain data sufficient for further analysis and statistical processing. All studies will be performed in comparison with stents made of stainless steel. In the course of research works commercialization plan will be developed. Current status. Pure iron is a promising material for the development of biodegradable implants. The iron stents could lose their mechanical stability prematurely due to their corrodible degradation. Previously, the experiments in the framework of A-1841 ISTC Project demonstrated that electroformed iron demonstrated more rapid degradation than cast iron. There is a necessity to continue the research aimed at design and development of new iron stents. The project’s influence on progress in this area. Development of optimal stents requires a systematic multidisciplinary approach to optimize the stent metal, stent design, polymer coatings. Currently the search is actual for iron cardiovascular stents of moderate and homogenous degradation. The newly proposed Project will focus on revealing the biological compatibility and degradation of electroformed iron devices in contact with blood under conditions in vitro and in vivo. The selection of entirely dissolving iron will become the base for development of iron biodegradable stents for further commercialization. The participants’ expertise. The project implementation team will include scientists, who took part in ISTC A-1841, A-1358, and A-948 projects. The scientists have significant experience in development thromboresistant coverings for metal stents, and pure iron stents. The researchers are highly professional in conducting experiments in laboratory animals. Expected results and their application. Research on biodegradation of iron stents with adjustable speed will have the practical importance in the field of safe stents design and development. The experiments in animals will show, whether the replacement of a constant stent with the bare stent will be sufficient to prevent the process of restenosis or it is necessary to cover the stent with the biodegradable covering containing antiproliferative preparations. Meeting the ISTC goals and objectives. Since former “weapons” scientists took part in this Project implementation and because it is exceptionally peaceful the Project meets the ISTC goals. Adherence to these objectives can be attained by planned wide involvement of scientists and participating institutions into international scientific community through providing information on the Project at international conferences and workshops. Scope of activities. The following activities will be implemented under the Project:
- preparation of electroformed iron
- obtainment of model iron stents;
- selection of thromboresistent coverings for iron and stainless steel (SS) stents;
-development of a polymer matrix for drug eluting stents (DES);
-comparison of stents in vivo and in vitro biodegradation;
-assessment and evaluation of medical-and-biological effects;
-experiment in animals with model stents;
- preparation of commercialization plan. Role of Foreign Collaborators/Partners. The Project planned collaboration with Professor K. Lee, the Collaborator from Republic of Korea. Professor K. Lee was also Collaborator of the previous Project A-1848. The role of collaborators will include providing consultations and assistance upon carrying out studies, as well as arrangement of joint workshops. Technical approach and methodology. Classical stage-by-stage scheme will be used for selection of hemocompatible materials: selection of metal samples and polymers according to physical-and-chemical properties; sterilization; toxicological analysis; studies on short- and long-term contact of a material with blood; in vitro and in vivo testing. The biological action of materials was evaluated taking into consideration recommendations of ISO Standard 10993. “Medical devices. Biological evaluation of medical devices”. Research will be performed using metal stents of electroformed iron: 1. Bare stents (BMS); 2. Stents with a polymer covering.
Participating Institutions
LEADING
Scientific Centre of Radiation Medicine and Burns (SCRMB)
