Evaluation of the Promesa™ JOY Self-Expanding Nitinol Peripheral Stent System's Safety and Performance in a Swine Model

Abstract

The Peripheral Stent System is engineered for the treatment of peripheral artery disease (PAD), particularly in cases involving the superficial femoral artery and proximal popliteal artery. PAD leads to the narrowing or blockage of arteries, primarily affecting the lower extremities, which can result in severe complications like limb ischemia. This stent system, composed of a self-expanding nitinol stent paired with an over-the-wire (OTW) delivery system, is designed to reopen and maintain the patency of affected arteries, thereby restoring adequate blood flow. It adheres to rigorous standards as a class C implantable medical device, with its regulatory status authenticated by notification S.O. 1468 dated October 6, 2005.  To assess its performance, the stent system was tested in a porcine model, specifically in the superficial femoral artery of three female pigs, chosen for their physiological similarities to human circulatory systems. The study included evaluations at six- and nine-months post-implantation, focusing on the deployment, patency, and vascular response of the stent. The results indicated that all animals remained healthy throughout the study, with no signs of morbidity or mortality. The stent system was deployed successfully in all cases, showing complete hemostasis and no blood leakage. Initial angiographic assessments revealed no early lumen loss; however, over time, some stenosis was observed 15% in one animal after six months and 10-12% in others after nine months. Histopathological analysis revealed moderate inflammation, mild to moderate vascular injury, and varying degrees of endothelial loss, with minimal to moderate fibrin deposition. Despite these findings, the stent system generally maintained vessel patency and blood flow, demonstrating its potential for clinical use in peripheral artery procedures. The study concluded that the Peripheral Stent System is safe and effective in this animal model, supporting its potential application for treating PAD in humans.

Keywords: Peripheral Stent System, Superficial femoral artery, Proximal popliteal artery, Nitinol stent, Porcine model, Deployment.