Advancing Venous Interventions: In-Vitro Evaluation of a Novel Self-Expanding Venous Stent System

Background: Venoplasty and venous stenting are commonly used to treat chronically thrombosed veins. However, venous angioplasty alone is often insufficient due to low intravascular pressure in the venous system, necessitating the use of metal stents for long-term patency. Venous outflow obstruction can lead to chronic venous insufficiency, pain, and mobility impairment, requiring precise medical intervention. The Self-Expanding Venous Stent System is an endovascular device designed to maintain vessel patency by providing structural support. It consists of a hybrid closed-cell nitinol stent and an over-the-wire delivery system, engineered for enhanced radial strength, flexibility, and deployment accuracy, while minimizing risks such as foreshortening and migration. Objectives: This study aimed to evaluate the in-vitro performance of the Self-Expanding Venous Stent System using a silicone-based venous channel model. Key performance parameters assessed included deployment accuracy, radial expansion, resistance to kinking, migration stability, and foreshortening characteristics, with comparisons to conventional stents. Method: A standardized in-vitro testing protocol was followed. The procedure began with the preparation of a saline-filled compliant venous channel model, simulating a venous environment. The delivery system was flushed using an air-free technique to ensure optimal function. A 0.035-inch guidewire was then introduced, followed by deployment of the over-the-wire stent. Post-deployment, the following assessments were conducted: Foreshortening analysis (percentage change from nominal length), Radial expansion measurement (stent diameter post-expansion vs. nominal diameter), Kink resistance evaluation (assessing flexibility under bending forces), Migration stability test (evaluating positional stability under simulated venous flow conditions) Results: The Self-Expanding Venous Stent System demonstrated accurate deployment with minimal foreshortening (≤ X%), even radial expansion (±X% of nominal diameter), and high kink resistance under bending forces. There was no observable migration during testing, indicating excellent stability. Compared to conventional stents, the system exhibited superior flexibility and radial strength, suggesting potential clinical benefits in maintaining long-term venous patency. Conclusion: The study findings validate the mechanical performance and clinical relevance of the Self-Expanding Venous Stent System in addressing venous outflow obstruction. Its enhanced deployment accuracy, flexibility, and stability make it a promising option for long-term treatment. However, further in-vivo studies and clinical trials are necessary to confirm long-term durability, endothelialization, and efficacy in real-world scenarios.