Postsurgical gastrointestinal fistulas remain a severe and persistent clinical challenge, often requiring multiple endoscopic procedures with limited long-term success. Current endoscopic therapies—clips, suturing systems, stents, and vacuum-assisted closure—are constrained by device migration, inadequate tissue apposition, heterogeneous healing, and the necessity for repeated interventions. Moreover, existing systems are usually non-biodegradable, requiring removal and adding procedural risk. A single-application therapy capable of providing simultaneous mechanical sealing, stable anchoring, and biologically supported healing is still lacking in therapeutic endoscopy.

We developed EndoFIS, a first-in-class biodegradable bioactive-mechanical device specifically engineered for endoscopic closure of gastrointestinal fistulas. The current prototype integrates: 1) A biodegradable anchoring component that traverses the fistulous orifice and stabilizes the system within the tract; 2) An intraluminal sealing balloon filled with a regenerative hydrogel, enabling immediate mechanical occlusion and sustained release of a re-epithelializing, antimicrobial matrix; 3) A catheter-based delivery system compatible with guidewire deployment for precise endoscopic positioning. These elements work synergistically to provide mechanical closure, active tissue approximation, and a pro-healing environment as the biodegradable materials progressively resorb. The design is fully aligned with the core functional claims of the supporting patent, including axial tissue-approximation dynamics and controlled bioactive release.

Ex vivo testing demonstrated reliable deployment through a working channel, secure anchoring across the fistulous orifice, and effective intraluminal sealing with strong mucosal adherence of the hydrogel. Benchtop modelling under simulated luminal pressures confirmed device stability, resistance to migration, and maintenance of configuration during cyclical loading.

In a porcine preclinical model, endoscopic placement was feasible, intuitive, and did not require retrieval. EndoFIS achieved successful sealing of the fistulous orifice, with correct anchoring and uniform hydrogel distribution at the target site. No device migration, obstruction, inflammatory reaction, or acute adverse events were observed. The integrated anchoring–balloon–hydrogel mechanism functioned as intended, validating the platform concept and supporting the transition to chronic evaluation.

EndoFIS introduces a new therapeutic paradigm for the endoscopic management of gastrointestinal fistulas by combining biodegradable anchoring, mechanical sealing, and bioactive tissue regeneration in a single, non-retrievable device. The ex vivo, benchtop, and in vivo findings demonstrate its safety, feasibility, and functional efficacy. This next-generation technology has the potential to improve clinical outcomes, reduce the need for repeated interventions, simplify therapeutic workflows, and decrease the environmental