Advertisement
Advertisement
March 6, 2026
BD’s Revello Vascular Stent Approved in Europe to Treat Iliac Arteries
KEY TAKEAWAYS
- Self-expanding covered stent receives CE Mark approval for treatment of atherosclerotic lesions in common and external iliac arteries.
- AGILITY clinical trial is evaluating the Revello’s performance in patients with PAD.
- Revello was introduced at LINC 2026 and will be launched across Europe.
March 6, 2026—BD (Becton, Dickinson and Company) announced it has obtained CE Mark approval for the Revello vascular covered stent for the treatment of atherosclerotic lesions in the common and external iliac arteries.
BD advised that the Revello stent will be launched in CE Mark-accepting countries across Europe. In the United States, it is an investigational device limited by federal law to investigational use only.
According to the company, the next-generation endovascular solution is designed to combine the flexibility of a nitinol self-expanding stent with radial resistive force tailored for the iliac arteries in patients with peripheral artery disease (PAD).
The press release stated that Revello features a self-expanding stent and an ultrathin expanded polytetrafluoroethylene covering to help keep iliac arteries open while conforming to vessel anatomy. Compliant stent ends help reduce the risk of trauma to healthy vessel segments and tantalum radiopaque markers enable clear visualization under fluoroscopy.
The stent is delivered via a triaxial delivery system designed for controlled deployment and accurate placement, noted the company.
After receiving CE Mark approval, the Revello stent was introduced in January at the LINC 2026 congress in Leipzig, Germany.
At LINC, Michael Lichtenberg, MD, discussed the ongoing AGILITY clinical trial, which is evaluating the Revello device’s performance in patients with PAD. Dr. Lichtenberg is the European Principal Investigator of the prospective, multicenter study.
“With the Revello stent, we have a very good new option for the treatment of iliac arteries,” commented Dr. Lichtenberg, as quoted in BD’s press release. “It stands out for its high radial force and low profile. The triaxial delivery system allows for very easy and precise placement.”
Advertisement
Advertisement