The project focused on the development and pre‑clinical evaluation of novel stent technologies for cardiology, ophthalmology, otolaryngology, gynecology, and gastroenterology. In cardiology, a multifunctional polymer‑drug coating was engineered for magnesium scaffolds to control support duration and degradation. The coating was tested for sterility, degradation kinetics, and drug release, demonstrating a sustained release profile compatible with the required therapeutic window. Biodegradable covered scaffolds were produced as bail‑out devices for life‑threatening vascular perforations; in vivo studies in animal models showed effective sealing of perforations with a reduced thrombosis risk compared to permanent stent‑grafts, which can reach up to 22 % after three years. The project also established an ex vivo model of vascular perforation and a standardized bifurcation model for simulated use testing, enabling systematic assessment of stent‑graft performance under clinically relevant geometries.
In ophthalmology, a drug‑eluting micro‑stent was developed with a fixation mechanism to prevent dislocation. In vitro and in vivo drainage capacity tests were performed, and an ex vivo ocular model was used to evaluate the stent’s ability to maintain aqueous humor outflow. The stent’s biocompatibility was confirmed through GLP‑compliant cytotoxicity assays following DIN EN ISO 10993 guidelines. For otolaryngology, drug‑release coatings were applied to both biodegradable and permanent tube stents, and degradation studies were conducted to ensure that the release kinetics matched the therapeutic needs of airway patency. The coatings were characterized morphologically and chemically, and their biocompatibility was assessed in vitro.
The gastroenterology subproject performed a comparative analysis of market‑available drug‑eluting stents, examining their morphological and mechanical properties. Ex vivo models were used to study perforation repair, and in vitro systems were established to evaluate the biological performance of biomaterials intended for gastrointestinal stents. Histological and immunohistochemical analyses of rabbit eyes implanted with glaucoma micro‑stents provided insight into tissue response and potential long‑term outcomes.
Collaboration across the project involved multiple partners. The University of Rostock’s Medical Center contributed the UMR (University Medical Research) subprojects, providing expertise in material science, in vitro testing, and animal studies. The Biotronik company supplied commercial stent‑grafts for comparative analysis, while other industry partners supplied polymer and metal components. The project was funded by the German Federal Ministry of Education and Research, with a structured timeline: by month 12 the market stents were evaluated, by month 27 the glaucoma stent testing methods were finalized, by month 30 the improved stent‑grafts were ready for clinical trials, and by month 33 the final designs for the Eustachian tube stents were selected for validation studies. The AP (Application Phase) and MS (Milestone) designations guided the decision points, ensuring that each technical milestone—such as the establishment of in vitro and in vivo testing protocols—was achieved before progressing to the next phase. This coordinated effort aimed to translate the developed stent technologies into clinically approved products while maintaining scientific continuity for future industrial partnerships.
