BD Unveils Advanced Iliac Artery Treatment with CE Mark in Europe
Advancing Iliac Artery Treatments in Europe
BD (Becton, Dickinson and Company), a leading medical technology firm, has made a significant advancement in treating common and external iliac artery lesions. The company recently announced the acquisition of CE Marking for its innovative Revello™ vascular covered stent, a next-generation solution aimed at addressing the complexities of peripheral artery disease (PAD) which is particularly prevalent among the aging population in Europe.
A Critical Development in Vascular Health
Peripheral artery disease, specifically affecting the iliofemoral region, can lead to considerable disabilities in older adults. The introduction of the Revello™ stent represents a vital step forward in the treatment of such conditions. Rima Alameddine, the Global President of BD Interventional – Peripheral Intervention, highlighted the significance of this CE marking, affirming BD’s commitment to enhancing treatments for complex iliac artery diseases across European Economic Area (EEA) countries.
The Revello™ stent is designed with a unique combination of flexibility and radial strength, engineered to stay open while conforming to the artery's anatomy. Its advanced structure includes a ultra-thin polytetrafluoroethylene coating, maintaining patency and preventing trauma to surrounding healthy tissues through its soft stent ends. Additionally, the device features tantalum radio-opaque markers that ensure precise placement and deployment even in challenging anatomical scenarios.
Enhanced Deployment System
The stent is deployed via a tri-axial delivery system, allowing for controlled release and meticulous positioning. This system includes an atraumatic tip for smooth insertion, a stability sheath for accurate placement, and an intuitive handle that permits real-time adjustments during deployment. Furthermore, the Revello™ stent offers a broader range of sizes and lower profile options, significantly minimizing the risk of access site complications.
Following its CE certification, the Revello™ stent was showcased at the LINC 2026 conference in Germany. Physicians exchanged insights on its potential impact on iliac interventions. Dr. Michael Lichtenberg, an angiologist, participated in discussions about the AGILITY clinical trial currently evaluating the stent's performance in PAD patients. This trial is being led by Dr. Sean Lyden from the Cleveland Clinic in Ohio, underlining BD’s efforts to drive clinical research and innovation.
According to Dr. Lichtenberg, the Revello™ stent stands out with its high radial strength and low profile. The tri-axial system simplifies the procedure, making it a promising option for vascular surgeons dealing with iliac artery cases.
Future Availability
With the CE marking in place, BD plans on launching the Revello™ stent across European countries that recognize this certification. However, it's worth noting that in the United States, the device remains experimental and is limited to investigational use only, as per regulations.
As the medical technology landscape continues to evolve, BD remains steadfast in its mission to produce clinically relevant innovations. Their goal is to enhance patient care by optimizing clinical operations, ultimately improving health outcomes. The introduction of the Revello™ stent marks just one of the many ways BD is making strides in vascular health and solidifying its position as a leader in medical technology advancements.