Polymer-based Stealth Coating of Hemocompatible and Absorbable Stents

Introduction

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.

Current Challenges

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
• Breakage

These issues lead to a high risk of patient mismatch, severe adverse events, a high rate of re-interventions, and high treatment costs.

Project Overview

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. It is coated with a zwitterionic polymer-based coating that prevents FBR.

Benefits of StealthStent

The potential benefits of the StealthStent resorbable stent are significant for adults due to its:

1. Enhanced performance against FBR
2. Decreased need for re-interventions

Design Optimization

During this project, we will optimize the stent design to improve its radial force, adjusting it to the several types of CHD. We will also optimize a zwitterionic polymer developed in the former FET-Open Project STARDUST, which was validated to address FBR but is not yet absorbable.

Expected Outcomes

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%.

Testing and Development

The coated stent will be tested in vitro and in vivo, resulting in a Technology Readiness Level (TRL) of 5 by the end of the project.

Business Strategy

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.