In-vitro and In-vivo GLP Evaluation of the Novel Bioresorbable Coronary Scaffolds; ArterioSorb™

新型生物可吸收冠状动脉支架的体外和体内 GLP 评估；

• 批准号: 102869
• 金额: $ 99.57万
• 依托单位: ARTERIUS LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2017
• 资助国家: 英国
• 起止时间: 2017 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=102869
• 关键词: vitro; vivo; GLP; Evaluation; Novel

ArterioSorb™ is an innovative medical implant product currently being developed by Arterius, a UK medical device micro/SME, to treat coronary artery disease (CAD). CAD is the leading cause of death both in the UK and worldwide, responsible for more than 73,000 deaths in the UK each year. ArterioSorb™ is a next-generation bioresorbable cardiovascular scaffold (BRS, stent), ArterioSorb™, to be implanted within the coronary arteries in order to open blocked vessels, and to biodegrade within two years when healing is complete and it is no longer needed. In this 24-month project, Arterius will perform the in-vitro and in-vivo studies necessary to demonstrate the safety and efficacy of ArterioSorb™. After completion of this study, the company will enter the First-in-Man trials and commercialisation, which will enhance the growth and global profile of the company, create new skilled jobs and enhance our global competitiveness in the field of stent technologies. There is currently no UK company offering a BRS for the global market. Following this project, ArterioSorb™ will launch to compete with the global BRS products. The goal of Arterius is to develop as a major UK SME with global competitiveness in the polymer based BRS market to treat cardiovascular disease.

ArterioSorb™ 是英国医疗器械微型/中小企业 Arterius 目前正在开发的一种创新医疗植入产品，用于治疗冠状动脉疾病 (CAD)。 CAD 是英国乃至全世界的首要死因，每年导致英国超过 73,000 人死亡。 ArterioSorb™ 是下一代生物可吸收心血管支架（BRS，支架）ArterioSorb™，可植入冠状动脉内以打开阻塞的血管，并在愈合完成且不再需要时在两年内生物降解。在这个为期 24 个月的项目中，Arterius 将进行必要的体外和体内研究，以证明 ArterioSorb™ 的安全性和有效性。这项研究完成后，公司将进入首次人体试验和商业化，这将增强公司的增长和全球形象，创造新的技术岗位，并增强我们在支架技术领域的全球竞争力。目前还没有英国公司为全球市场提供 BRS。该项目结束后，ArterioSorb™ 将推出与全球 BRS 产品竞争。 Arterius 的目标是发展成为一家在治疗心血管疾病的聚合物 BRS 市场上具有全球竞争力的英国主要中小企业。