Title: Development of a novel biodegradable device for the potential closure of postoperative fistulas

Authors: Marina García-Castellanos, Vicente Lorenzo-Zúñiga, Guillermo Vilariño- Feltrer, Isabel Tort-Ausina, Rubén Martín-Cabezuelo, Vicente Pons Beltrán, Alberto Campillo-Fernández.

Postoperative fistulas remain a frequent and challenging complication, particularly after gastrointestinal and colorectal surgeries, often leading to prolonged hospitalization, infection, and increased morbidity. Current closure techniques, including clips, sutures, and negative pressure therapies, present important limitations. To address these shortcomings, a novel biodegradable device has been developed, combining a 3D-printed anchoring structure with a molded globular component designed to seal the fistulous tract securely. The anchoring element ensures mechanical stability, while the globular component provides a flexible and adaptable seal, reducing risks of leakage or migration. The design and manufacturing process followed an iterative approach, integrating in vitro and ex vivo testing to optimize deployment, fixation, and sealing capacity. This integrated system aims to minimize the need for secondary procedures, improve patient safety, and reduce healthcare resources. By offering an innovative approach to fistula management, this work highlights the potential of combining advanced manufacturing techniques with functional design to achieve a clinically effective and sustainable solution.