International Journal of Medical Laboratory Research (IJMLR)

PRECLINICAL FEASIBILITY STUDY EVALUATING THE SAFETY AND PERFORMANCE OF THE COREVIVE™ COLONIC STENT SYSTEM IN A PORCINE MODEL

 

PK Minocha, DK Kothwala, K Shah, K Pandya, R Ladumor, H Solanki, D Desai

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ABSTRACT: Colonic stents are widely used to restore bowel patency in cases of obstruction, serving as both palliative treatment and a bridge to surgery. This feasibility study evaluated the safety and performance of the CoRevive™ Colonic Stent System in a porcine model. A single healthy male pig (n=1) underwent endoscopic- and fluoroscopic-guided colonic stent implantation under general anesthesia. Device deployment, lumen patency, and tissue response were assessed using fluoroscopy and endoscopy on Days 0, 14, and 44 post-implantations. The procedure was successfully completed with accurate stent placement and no complications. The animal remained clinically stable, with body weight increasing from 52.9 kg to 65.3 kg. Post-procedural pain was moderate and resolved within four days. Imaging demonstrated immediate luminal expansion with sustained patency at Day 44. Histopathological analysis showed mild inflammatory response and complete endothelialization, indicating favorable biocompatibility. These preliminary findings suggest that the device is feasible and demonstrates acceptable short-term safety and performance. Further studies in larger cohorts and disease-specific models are required to confirm these results.

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Keywords: CoRevive™ (Colonic Stent System), Porcine Model, Radiography analysis, Endoscopy analysis and Histopathological

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