BD Secures European Approval for Iliac Artery Stent Treatment

BD (Becton, Dickinson and Company) has obtained CE Marking for the Revello Vascular Covered Stent, a next-generation endovascular solution for treating atherosclerotic lesions in the common and external iliac arteries.

The authorization arrives at a pivotal moment, according to BD, as lower‑extremity peripheral artery disease (PAD)—of which iliac artery disease is a key component—drives a substantial disability burden across the EU’s aging population.^1,2 The Revello Vascular Covered Stent is designed to combine the flexibility of a nitinol self-expanding stent with the radial resistive force tailored for the iliac arteries.

“The CE Marking of the Revello Stent is a significant advancement towards helping physicians treating complex iliac artery disease,” said Rima Alameddine, worldwide president, BD Interventional – Peripheral Intervention. “The Revello Vascular Covered Stent was built to raise the standard of iliac artery revascularization, expand the growing BD peripheral vascular portfolio, and reinforce the company’s commitment to delivering clinically relevant innovation for physicians treating complex PAD across EU and EEA countries.”

The Revello Stent is a self-expanding stent with an ultra-thin expanded polytetrafluoroethylene covering, designed to help keep iliac arteries open while conforming to vessel anatomy. This feature is supported by compliant stent ends designed to help reduce the risk of trauma to healthy vessel segments. For placement accuracy, the stent features tantalum radiopaque markers, enabling clear visualization under fluoroscopy—even in challenging anatomy.

The Revello Stent is delivered through a tri-axial delivery system for controlled deployment and accurate placement. The system includes an atraumatic tip for smooth insertion, a stability sheath for smooth and precise delivery, and a thumbwheel that provides intuitive control and precise adjustments during deployment. Available in a wide range of sizes, the Revello Stent offers more diameters on a lower profile platform compared to self-expanding iliac artery stents in the European market, which can help reduce the risk of access site complications.³ Multiple catheter length options further support procedural versatility.

Following receipt of the CE Mark, the Revello Stent was introduced at the LINC 2026 congress in Germany, where physicians discussed its potential impact on iliac interventions.

Physician and Angiologist, Dr. Michael Lichtenberg highlighted the ongoing AGILITY clinical trial, which is evaluating the device’s performance in patients with PAD. This trial is a prospective, multi-center study led by global principal investigator, Dr. Sean Lyden, chairman of the Department of Vascular Surgery at Cleveland Clinic in Cleveland, Ohio, and Dr. Lichtenberg, European principal investigator.

“With the Revello Stent, we have a very good new option for the treatment of iliac arteries,” Dr. Lichtenberg stated. “It stands out for its high radial force and low profile. The triaxial delivery system allows for very easy and precise placement.”

The Revello Stent will be launched in CE-mark-accepting countries across Europe. In the United States, it is an investigational device limited by U.S. law to investigational use only.

BD is one of the world’s largest pure-play medical technology companies that drives innovation across medical essentials, connected care, biopharma systems, and interventional solutions. Operating globally with more than 60,000 employees, BD delivers billions of products annually that impact global healthcare. By working in close collaboration with customers, BD aims to help enhance outcomes, lower costs, increase clinical efficiency, improve safety, and expand access to healthcare.

References
¹ Houghton JSM, Saratzis AN, Sayers RD, Haunton VJ. New horizons in peripheral artery disease. Age Ageing. 2024;53(6). doi:10.1093/ageing/afae114
² Xu YY, Zeng XX, Tu WJ. Editorial: Pathophysiology, treatment and rehabilitation of atherosclerosis related diseases in the geriatric population. Front Med. 2024;11. doi:10.3389/fmed.2024.1358769
³ Cacuci AC, Krankenberg H, Thieme M, et al. Access site complications of peripheral endovascular procedures: A large, prospective registry on predictors and consequences. J Endovasc Ther. 2025;28(5):451‑463. doi:10.1177/15266028211025044