In-House Fabrication and Validation of 3D-Printed Custom-Made Medical Devices for Planning and Simulation of Peripheral Endovascular Therapies

<b>Objectives:</b> This study aims to develop and validate a standardized methodology for creating high-fidelity, custom-made, patient-specific 3D-printed vascular models that serve as tools for preoperative planning and training in the endovascular treatment of peripheral artery disease (PAD). <b>Methods:</b> Ten custom-made 3D-printed vascular models were produced using computed tomography angiography (CTA) scans of ten patients diagnosed with PAD. CTA images were analyzed using Syngo.via by a specialist to formulate a medical prescription that guided the model's creation. The CTA data were then processed in OsiriX MD to generate the .STL file, which is further refined in a Meshmixer. Stereolithography (SLA) 3D printing technology was employed, utilizing either flexible or rigid materials. The dimensional accuracy of the models was evaluated by comparing their CT scan images with the corresponding patient data, using OsiriX MD. Additionally, both flexible and rigid models were evaluated by eight vascular surgeons during simulations in an in-house-designed setup, assessing both the technical aspects and operator perceptions of the simulation. <b>Results:</b> Each model took approximately 21.5 h to fabricate, costing €140 for flexible and €165 for rigid materials. Bland-Alman plots revealed a strong agreement between the 3D models and patient anatomy, with outliers ranging from 4.3% to 6.9%. Simulations showed that rigid models performed better in guidewire navigation and catheter stability, while flexible models offered improved transparency and lesion treatment. Surgeons confirmed the models' realism and utility. <b>Conclusions:</b> The study highlights the cost-efficient, high-fidelity production of 3D-printed vascular models, emphasizing their potential to enhance training and planning in endovascular surgery.