BD Receives CE Mark for Revello™ Vascular Covered Stent, Expanding PAD Treatment Options in Europe
BD (Becton, Dickinson and Company) has announced the receipt of CE Marking for its Revello™ Vascular Covered Stent, a novel endovascular solution designed for treating atherosclerotic lesions in the common and external iliac arteries. This milestone addresses a significant require, as peripheral artery disease (PAD), particularly iliac artery disease, impacts a growing aging population across the European Union.
Addressing the Challenges of Iliac Artery Disease
The Revello™ Stent combines the flexibility of a nitinol self-expanding stent with radial resistive force specifically tailored for the iliac arteries. This design aims to improve outcomes for patients suffering from iliac artery disease, a condition that can cause significant disability.
Key Features of the Revello™ Vascular Covered Stent
The Revello™ Stent incorporates several features designed to enhance performance and patient safety:
- Ultrathin Expanded Polytetrafluoroethylene Covering: Helps maintain artery openness while conforming to vessel anatomy.
- Compliant Stent Ends: Designed to minimize trauma to healthy vessel segments.
- Tantalum Radiopaque Markers: Enable clear visualization during fluoroscopy, even in complex anatomy.
- Tri-Axial Delivery System: Provides controlled deployment and accurate placement, featuring an atraumatic tip and a stability sheath.
- Wide Range of Sizes: Offers more diameters on a lower profile platform compared to existing iliac artery stents in the European market, potentially reducing access site complications.
AGILITY Clinical Trial Continues to Evaluate Performance
The Revello™ Stent is currently being evaluated in the ongoing AGILITY clinical trial, a prospective, multi-center study led by Dr. Sean Lyden of the Cleveland Clinic and Dr. Michael Lichtenberg. Dr. Lichtenberg highlighted the stent’s high radial force, low profile and ease of placement thanks to its triaxial delivery system.
“With the Revello™ Stent, we have a very good new option for the treatment of iliac arteries,” said Dr. Lichtenberg.
European Launch and Availability
Following CE Mark approval, the Revello™ Stent was introduced at the LINC 2026 congress in Germany. It will be launched in CE-mark-accepting countries across Europe. In the United States, the device remains investigational.
Future Trends in Peripheral Artery Disease Intervention
The approval and launch of the Revello™ Stent signal several key trends in the treatment of PAD:
- Focus on Iliac Artery Disease: Increased attention is being paid to the iliac arteries, recognizing their importance in overall PAD management.
- Advancements in Stent Technology: Continued innovation in stent design, materials, and delivery systems is leading to improved outcomes and reduced complications.
- Minimally Invasive Procedures: Endovascular interventions, like those enabled by the Revello™ Stent, are becoming increasingly preferred over traditional open surgery.
- Personalized Medicine: The development of stents with varying sizes and features allows for more tailored treatment approaches based on individual patient anatomy and disease characteristics.
FAQ
- What is the Revello™ Stent used for? The Revello™ Stent is used to treat atherosclerotic lesions in the common and external iliac arteries.
- What is CE Marking? CE Marking indicates that a product meets EU safety, health, and environmental protection requirements.
- Is the Revello™ Stent available in the US? No, It’s currently an investigational device limited to investigational use in the United States.
Pro Tip: Early diagnosis and intervention are crucial for managing PAD. If you experience symptoms such as leg pain, cramping, or numbness, consult with a vascular specialist.
Learn more about BD’s commitment to advancing the world of health at bd.com.
