Becton Dickinson Receives EU CE Mark for Revello Iliac Artery Stent
Becton, Dickinson and Company received EU CE Mark approval for its Revello Vascular Covered Stent, a self-expanding nitinol device with an ultrathin PTFE covering for iliac artery lesions. The clearance expands BD’s peripheral artery disease portfolio and positions it in the EU market valued at $3.17 billion in 2025.
1. CE Mark Approval Expands EU Access
Becton Dickinson has obtained CE Mark approval for its Revello Vascular Covered Stent in the European Union, enabling the device’s commercialization across EU member states. This regulatory clearance marks the first major approval for Revello, positioning BD in the iliac artery intervention segment.
2. Device Design and Clinical Attributes
The Revello Stent features a self-expanding nitinol frame with an ultrathin PTFE covering, compliant ends to reduce vessel trauma and radiopaque markers for precise fluoroscopic placement. Its tri-axial delivery system with a stability sheath and thumbwheel mechanism supports controlled deployment and procedural flexibility.
3. Market Opportunity in Peripheral Artery Disease
The EU peripheral artery disease treatment market was valued at $3.17 billion in 2025 and is growing with an aging population. CE Mark approval allows BD to capture incremental iliac artery procedure volumes and strengthen recurring interventional revenue streams in its vascular portfolio.