BD receives CE mark for Revello vascular covered stent

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Revello vascular covered stent

BD today announced it has obtained CE marking for the Revello vascular covered stent, which the company describes as a next-generation endovascular solution for the treatment of atherosclerotic lesions in the common and external iliac arteries.

The Revello stent is designed to combine the flexibility of a nitinol self-expanding stent with the radial resistive force tailored for the iliac arteries. The stent features an ultrathin expanded polytetrafluoroethylene covering, compliant stent ends and, for placement accuracy, tantalum radiopaque markers.

“Revello is delivered via a triaxial delivery system designed 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,” BD notes in a press release. The company adds that the stent is available in a wide range of sizes.

Following receipt of the CE mark, the Revello stent was introduced at the 2026 Leipzig Interventional Course (LINC; 27–31 January, Leipzig, Germany), where physicians discussed its potential impact on iliac interventions.

Michael Lichtenberg (Arnsberg Clinic, Arnsberg, Germany) highlighted the ongoing AGILITY clinical trial, which is evaluating the device’s performance in patients with peripheral arterial disease (PAD). This trial is a prospective, multicentre study led by Sean Lyden (Cleveland Clinic, Cleveland, USA) as global principal investigator (PI) and Lichtenberg as European PI.

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

BD advises that, in the USA, the Revello stent is an investigational device limited by US law to investigational use only.


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