Franklin Lakes, New Jersey-based BD designed Revello to treat atherosclerotic lesions in the common and external iliac arteries. The next-generation endovascular solution combines the flexibility of a nitinol self-expanding stent with the radial resistive force tailored for the iliac arteries.
Revello features an ultra-thin, expanded polytetrafluoroethylene covering. The company designed it to help keep iliac arteries open while conforming to vessel anatomy. Compliant stent ends support this to reduce the risk of trauma to healthy vessel segments. The stent also features tantalum radiopaque markers, enabling clear visualization under fluoroscopy to ensure placement accuracy.
Delivery for Revello takes place through a tri-axial system with an atraumatic tip for smooth insertion, a stability sheath for smooth and precise delivery and a thumbwheel for intuitive control and precise adjustments during deployment.
BD said European approval comes as lower-extremity peripheral artery disease (PAD) — in which iliac artery disease is a key component — drives a “substantial disability burden” within the aging population of the European Union.
Following CE mark, BD introduced Revello at the LINC 2026 congress in Germany. It plans to begin rolling out the stent in CE mark-accepting countries across Europe. Revello remains investigational in the U.S. The company completed enrollment in the AGILITY pivotal study of the stent last year.
“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.”
