First-in- Human (FIH) Trials of a Novel Bioresorbable Coronary Scaffold (ArterioSorb™)

Arterius Ltd, a UK SME based in Leeds, and Afortiori Ltd, a UK based SME are planning to initiate first human trials of it's novel bioresorbable scaffold (stent) (BRS), ArterioSorb-BRS in 2019, having passed pre-clinical evaluations with an excellent data due to the support of the Innovate UK grants. ArterioSorb-BRS is designed to treat coronary artery disease -- narrowing of the coronary arteries due to fatty deposits within the vessels. This device has the potential to improve the lives the 92,000 people who undergo percutaneous coronary intervention (PCI) procedures within the UK every year.

The ArterioSorb-BRS scaffold is made from a biocompatible, bioresorbable polymer poly(L-lactic acid) (PLLA), and it has a wall thickness of 95 microns (finer than an average human hair), which is significantly thinner than first-generation BRS. This will lead to lower rates of late stent thrombosis, caused by disruption to the arterial blood flow by the struts and causing turbulent flow. Less thrombosis means less repeat vascularisations, each costing approx £17,500 per procedure, a considerable saving to the NHS. The thinner struts will also allow the treatment of smaller diseased arteries (<2.5mm), currently unavailable to the current BRS.

ArterioSorb's novel design was developed in collaboration with University of Southampton, and the manufacturing process is based on a proprietary die drawing technique originally developed in collaboration with polymer IRC team at the University of Bradford to significantly increase the material's strength. ArterioSorb-BRS is the thinnest and strongest non-metallic biodegradable scaffold in the world, and independent tests back this up. This First-Human trial of the ArterioSorb-BRS device is an innovative project which aims to commercialise the next-generation BRS. During this project, the company will complete the first in man (FIM) clinical trials with this product. The completion of the FIM trials will allow the company to enter the CE Mark trials and undertake commercialisation by 2023. Commercialisation of the ArterioSorb-BRS BRS will allow Arterius to grow and develop further innovative vascular bioresorbable products to treat a range of pathologies, enhancing the quality of life of many people. It will also create a range of new skilled jobs and increase the reputation and competitiveness of West Yorkshire region as a biotechnology hub within the UK.