Development and proof-of-concept of an in vitro mesoscale pipeline for the biomechanical assessment of coating transfer and persistence onto the arterial wall in drug coated balloons

Drug-coated balloons (DCBs) are designed to deliver therapeutic agents to the vessel wall during inflation, yet in practice only a limited fraction of the nominal dose is effectively transferred and retained, with performance varying widely across devices. We developed an in vitro mesoscale testing pipeline to quantify coating transfer to arterial tissue and its persistence after flow restoration. The method combines controlled cylindrical stamping of DCB coatings onto porcine arterial samples with optical quantification before and after exposure to physiological flow conditions. In this proof-of-concept study, approximately 66% of the initial coating was transferred to the artery, with about 56% of this amount embedded within the tissue. After flow exposure, the overall coating persistence averaged ∼37% of the initial dose. The protocol demonstrated high repeatability and low inter-sample variability. This approach provides a robust and scalable framework for systematic comparison of DCB technologies, enabling improved evaluation and optimization of drug delivery performance.