FDA approves new venous stent for deep venous disease in Jan 2026 – Key Points
FDA approves new venous stent for deep venous disease in Jan 2026 – Key Points
• A first-of-its-kind FDA approval for a stent specifically designed for deep venous disease, rather than the traditional off-label use of arterial stents.
• Designed to treat deep venous disease involving the IVC, iliac, and iliofemoral veins.
• Self-expanding
• Clinical evidence
• FDA decision based on data presented at the VEINS Conference (Nov 2025).
• International trial of 89 patients with deep venous disease.
• 12-month primary patency: 83.4%.
• No reported stent embolization/migration, fractures, vascular injuries, or clinically significant pulmonary embolism.
