BD Reaches Milestone in Study of Revello Vascular Covered Stent

BD (Becton, Dickinson and Company) announced full enrollment of the iliac artery patient cohort in its pivotal AGILITY investigational device exemption (IDE) study evaluating the Revello vascular covered stent in patients with peripheral artery disease (PAD).

The study, according to the company, is the latest advancement in self-expanding covered stent technology. It aims to address the clinical need for more flexibility, deliverability, and low-profile performance to treat challenging PAD lesions.

The AGILITY study is being conducted in up to 45 site in the U.S., Europe, Australia, and new Zealand. It will evaluate the safety and effectiveness of the Revello stent to treat de novo or restenotic lesions in two patient cohorts.

One cohort, the common and external iliac artery, is now fully enrolled. Enrollment is ongoing for the superficial femoral proximal popliteal artery cohort.

The announcement was made in conjunction with a late-breaking clinical trial presentation at the VIVA (Vascular InterVentional Advances) 2025 conference by Dr. Sean Lyden, chairman of the Department of Vascular Surgery at Cleveland Clinic in Cleveland, Ohio, and global lead principal investigator for AGILITY.

“Achieving full enrollment of the iliac cohort marks a critical milestone for the AGILITY study and for patients living with peripheral arterial disease,” said Dr. Lyden. “As our understanding of PAD deepens, the demand for innovative technologies that can expand our treatment options becomes increasingly critical.”

“This milestone reinforces the commitment of BD to advancing clinically meaningful innovation in endovascular care,” said JD Meler, MD, FSIR, VP of BD Enterprise Pre-Clinical Strategy and Medical Innovation. “The Revello Vascular Covered Stent is our next generation system, designed to support physicians and help optimize outcomes for patients.”

Last month, the company introduced the Incada connected care platform, a scalable, artificial intelligence (AI)-enabled, cloud-based platform that unifies BD device data into one intelligent ecosystem.