Safety and Efficacy of a Developed ‘Patent Ductus Arteriosus Occluder Device’: A Porcine Model Analysis Over Multiple Time Points

This study assessed the safety and performance of a patent ductus arteriosus (PDA) occluder using a porcine carotid artery model involving three male pigs. Each pig underwent a thorough physical examination and met the criteria for stable health and body weight. On day 0, the occluder was implanted under proper analgesia and anesthesia, with heparin used to prevent clot formation. The deployment process was meticulously evaluated through angiography and Quantitative Vascular Analysis (QVA) before and after implantation. Arteries were harvested at 90, 180, and 365 days for histopathological analysis. The occluder fulfilled all acceptance criteria, demonstrating successful deployment, trackability, and no cranial artery flow above the device. Gross necropsy showed a bulged carotid artery, suggesting a reaction to the device, while histopathological evaluations showed good endothelialization at all time points. The occluder was well-visualized during imaging, deployed easily, and could be withdrawn without issue. It effectively occluded the artery at all follow-ups without migrating from the target site. All animals survived the procedure and post- procedural period with the device intact. These results suggest that the PDA occluder is safe and effective in this model, showing promise for future human clinical applications, though further studies are needed to confirm long-term safety and efficacy.