Evaluating the Safety and Efficacy of Developed Self-Expanding Venous Stent System in a Porcine Model

The study evaluated the safety and performance of the self-expanding venous stent system in a porcine model. The research was conducted following the guidelines of Cardiovascular Implants—Endovascular devices-: Vascular stents (ISO 25539:2020). The study involved three female pigs that were fasted overnight without water access. All animals passed the physical examination criteria without major clinical observations or weight loss. Procedures were performed on days 0, 30, 90, and 180 under proper analgesia and anesthesia. The stented veins were harvested for histopathological evaluation on different days. The study concluded that the self-expanding venous stent system demonstrated ease of deployment and withdrawal, with no immediate restenosis or lumen loss post-implantation. Restenosis percentages were observed at 30, 90, and 180 days, matching angiographic evaluations. Histopathological findings showed complete endothelialization, moderate inflammation, and mild to moderate vascular and muscular injury. Throughout the study, no animals exhibited clinical concerns, indicating the safety and effectiveness of the self-expanding venous stent system in a porcine model over 30, 90, and 180 days.