Polymer-based Stealth Coating of Hemocompatible and Absorbable Stents

ongoing

Congenital Heart Diseases (CHD) are the most common type of birth defect, affecting more than 1,400,000 newborns annually. About 40% of these children need a stent treatment before they are fully grown, however there is no specific treatment for pediatric patients. The current standard of care is the off-label use of permanent stents designed for adults which is heavily affected by Foreign Body Reaction (FBR), stent migration and breakage. This leads to a high risk of patient mismatch, severe adverse events, high rate of re-interventions and high treatment costs. The StealthStent consortium is developing the world’s first stent explicitly designed for treating CHD in children. The StealthStent is made of an absorbable material that dissolves in 6 months allowing vessel growth and it is coated with a zwitterionic polymer-based coating that prevents FBR. The potential benefits of StealthStent resorbable stent are significant for adults thanks to its enhanced performance against FBR and decreased need for re-interventions. During this project, we will optimise the stent design to improve its radial force for adjusting it to the several types of CHD. We will optimise a zwitterionic polymer which was developed in the former FET-Open Project STARDUST and validated to address FBR but not yet absorbable. The polymer will be applied to an absorbable stent, which for the first time, could solve the unmet growth problem of current stents for children and significantly improve the standard of care for adults. Based on results obtained so far and on the planned development, we expect the StealthStent will reduce the risk of FBR, breakage, and migration to ≤5%. The coated stent will be tested in vitro and in vivo, resulting in a TRL 5 by the end of the project. Simultaneously, we will further develop and constantly update a business plan to outline the roadmap until market entry and we will further develop our go-to-market strategy.