Project description
First stent for children with congenital heart diseases
Congenital heart diseases (CHDs) affect over 1.4 million newborns each year, with 40 % requiring stent treatment. However, the off-label use of adult stents in children carries serious risks, including foreign-body reaction (FBR), stent migration, and breakage, which drive up treatment costs and complications. With this in mind, the EIC-funded StealthStent project will develop the first stent specifically designed for children with CHD. Made from a fully absorbable material that dissolves within six months, the stent allows for natural vessel growth. It also features a zwitterionic polymer coating to prevent FBR. While tailored for children, this innovation could also benefit adults by reducing the need for repeat procedures and improving long-term outcomes.
Objective
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.
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- natural sciences chemical sciences polymer sciences
- engineering and technology materials engineering coating and films
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Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
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HORIZON.3.1 - The European Innovation Council (EIC)
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Call for proposal
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(opens in new window) HORIZON-EIC-2024-TRANSITION-01
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2800 Kgs Lyngby
Denmark
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