BD Receives CE Mark Approval for Revello Vascular Covered Stent to Treat Peripheral Artery Disease
核心洞察
BD (搜索) (Becton, Dickinson and Company) has received CE Mark approval in the European Union for its Revello Vascular Covered Stent (搜索), designed to treat atherosclerotic lesions (搜索) in the common and external iliac arteries (搜索).
The company has completed enrollment of 118 patients in the iliac artery cohort of the AGILITY clinical study, with total enrollment expected to exceed 300 participants across multiple regions.
The Revello stent combines a self-expanding nitinol stent with an ultrathin expanded polytetrafluoroethylene covering and features a tri-axial delivery system for controlled deployment.
BD (搜索) (Becton, Dickinson and Company) has achieved a significant regulatory milestone with the receipt of CE Mark approval in the European Union for its Revello Vascular Covered Stent (搜索), designed to treat atherosclerotic lesions (搜索) in the common and external iliac arteries (搜索). This approval expands BD's peripheral vascular portfolio and strengthens its position in the growing peripheral artery disease (搜索) (PAD (搜索)) treatment market.
The regulatory approval comes alongside another important development in the device's clinical evaluation. BD (搜索) has successfully completed enrollment for the iliac artery patient cohort in the AGILITY clinical study, enrolling 118 patients as part of the comprehensive evaluation of the Revello stent's safety and effectiveness.
Advanced Stent Technology for Complex Vascular Conditions
The Revello Vascular Covered Stent (搜索) represents BD (搜索)'s latest innovation in self-expanding covered stent technology. The device combines a self-expanding nitinol stent with an ultrathin expanded polytetrafluoroethylene covering, allowing it to maintain vessel openness while adapting to natural vessel anatomy. Its compliant stent ends are intended to minimize trauma to healthy vessel segments, while tantalum radiopaque markers improve visibility under fluoroscopy, enabling physicians to position the stent accurately even in complex anatomical settings.
The device is delivered through a tri-axial delivery system that is engineered to support controlled deployment and precise placement during procedures. The system features an atraumatic tip for smoother insertion, a stability sheath for improved delivery control and a thumbwheel mechanism that allows physicians to make fine adjustments during deployment. The stent is also available in a wide range of diameters and catheter lengths, providing greater procedural flexibility.
AGILITY Clinical Study Progress
The AGILITY study is a prospective, multicenter clinical trial designed to evaluate the safety and effectiveness of the Revello Vascular Covered Stent (搜索) in patients with PAD (搜索). The trial is being conducted across up to 45 investigational sites in regions including the United States, Europe, Australia, and New Zealand.
Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at the Cleveland Clinic and global lead principal investigator for the AGILITY study, highlighted the importance of this milestone, noting that innovative technologies are essential for expanding treatment options for patients living with PAD (搜索). The study focuses on patients with arterial lesions that may be either newly developed or recurring after previous treatment.
With the completion of the iliac artery cohort enrollment, another group within the study continues to enroll patients with lesions in the superficial femoral and proximal popliteal arteries (搜索), bringing the total expected enrollment to more than 300 participants.
Addressing a Growing Medical Need
Peripheral artery disease (搜索) affects more than 200 million people globally, making it a significant public health concern. PAD (搜索) is a circulatory condition in which narrowed or blocked arteries restrict blood flow to the limbs. Patients often experience leg pain, limited mobility, and in severe cases face risks such as tissue damage or limb loss.
The global peripheral arterial disease treatment market size was estimated at $3.17 billion in 2025 and is forecasted to reach around $6.11 billion by 2034, expanding at a CAGR of 7.56% from 2025 to 2034. Growth of the market is attributed to the rising disease prevalence, increased adoption of minimally invasive technologies and ongoing innovation by leading medical device companies.
Market Introduction and Future Outlook
Following the CE Mark clearance, BD (搜索) introduced the Revello Stent at the LINC 2026 congress in Germany. The device is currently being evaluated in the AGILITY clinical trial to assess its performance in patients with peripheral artery disease (搜索).
As the AGILITY study continues, researchers will evaluate clinical outcomes including safety, patency rates, and long-term patient improvements. Data generated from the study will contribute to a deeper understanding of how next generation stent technologies perform in real world clinical settings.
The CE Mark approval positions BD (搜索) to capture incremental procedure volumes and expand its share in iliac artery treatments as PAD (搜索) becomes more common among Europe's aging population. A broader portfolio of minimally invasive vascular solutions also allows BD to deepen relationships with physicians and hospitals, potentially supporting steady device sales and recurring procedure-driven revenue.