JVS - Vascular Science (Jan 2023)
Evaluation of safety and performance of a new prototype self-expandable nitinol venous stent in an ovine model
Abstract
Objective: Our study was a prospective in vivo study performed on an animal model to evaluate the safety and performance of a novel venous stent designed specifically for venous applications. Methods: The novel stents were implanted in the inferior vena cava of nine sheep. The stents were deployed with different distances between the closed cell rings to test for if the segments might migrate after being deployed at maximal distance. Three different total lengths were 9, 11, and 13 cm. After 1, 3, and 6 months, vascular injury, thrombus, neointima coverage, and stent migration were evaluated through computed tomography venography and histopathology. Imaging, histology, and integration data were analyzed for each group. Results: All stents were deployed successfully, and all sheep survived until the time of harvesting. In all cases, the native blood vessel sections were intact. The segmented stent parts showed a differently pronounced tissue coverage, depending on the duration of the implantation. Conclusions: The new nitinol stent is safe and feasible to implant in the venous system with a rapid surface coverage. Alteration of stent length did not affect the development of neointimal formation and did not cause migration. : Clinical Relevance: The clinical relevance of our study titled ''Evaluation of Safety and Performance of a New Prototype Self-Expandable Nitinol Stent in an Ovine Model'' lies in its potential to advance the field of venous intervention. Stent implantation is a common procedure used to treat deep venous obstruction, and the use of self-expandable nitinol stents has been shown to be effective in improving the patency rates. However, the safety and efficacy of new stent prototypes must be evaluated thoroughly before they can be used in clinical practice. Our study contributes to the evaluation of a new prototype self-expandable nitinol stent by demonstrating its excellent mechanical properties, biocompatibility, and histopathological response in an ovine model. The results of our study may provide valuable insight for researchers and clinicians in developing and implementing new stent technologies, ultimately improving patient outcomes in the treatment of chronic venous obstruction.
