Pre-clinical Evaluation of a Novel Biodegradable Coronary Stent Prototype

前三代心血管永久性裸金属支架（BMS）和药物洗脱支架（DES）技术在过去的20年里取得了显著的发展，支架材料、设计和药物洗脱方面的进步旨在改善支架的可输送性、安全性和长期有效性。然而，这些永久性金属植入物的临床性能并不理想，因为它们可能在BMS的情况下诱导再狭窄（再狭窄）或在DES的情况下诱导晚期凝血（血栓形成）。下一代支架将是可生物降解的，从而为克服永久性支架治疗冠状动脉闭塞性疾病的局限性提供了额外的选择。理想的可生物降解支架材料是完全可生物降解的、血管相容的、高径向强度的，并且使用标准X射线和MRI方法可见。这些支架使动脉无法愈合，然后慢慢消失。目前可生物降解支架的高成本和临床局限性限制了其在临床实践中的应用。Arterius是唯一一家总部位于英国的SME开发新一代新型生物降解心血管支架，以解决这些局限性，旨在显著改善更多患者的预后。Arterius现在希望使用新开发的优化支架生产技术对这种新型原型设备进行临床前评估。TSB在SMART计划下的开发资金支持将大大帮助该公司在竞争中处于领先地位，并继续目前与三所大学的合作英国（即布拉德福德、南安普顿和谢菲尔德）进一步开发这个令人兴奋的项目，并在2015年前开始临床试验。

The first three generations of cardiovascular permanent bare metal stent (BMS) and drugeluting stent (DES) technology have developed significantly over the last twenty years withadvances in stent material, design and drug elution aimed at improving stent deliverability,safety and long term efficacy. However, the clinical performance of these permanent metallicimplants is not considered ideal as they can induce either re-narrowing (restenosis) in the caseof BMS or late clotting (thrombosis) in the case of DES to diseased coronary arteries. Thenext generation of stents will be biodegradable thereby offering additional options toovercome the limitations of permanent stents for the treatment of occlusive coronary arterydisease. The ideal biodegradable stent material is fully biodegradable, vascular compatible,high radial strength, and visible using standard X-Ray and MRI methodology. These stentsallow arteries to heal and then they slowly disappear. The high cost and the clinical limitationsof the currently available biodegradable stent are restricting its adoption into clinical practice.Arterius is the only UK-based SME developing the next generation of novel biodegradablecardiovascular stents to address these limitations with aim of significantly improvingoutcomes for more patients. Arterius now wishes to use newly-developed optimised stentproduction techniques to conduct pre-clinical evaluations of this novel prototype device.Development funding support from TSB under the SMART Scheme will significantly helpthe company to be ahead of the competition and to continue the current collaborate with thethree universities in the UK (namely Bradford, Southampton and Sheffield) to develop thisexciting project further and to commence clinical trials by 2015.