BD Completes Enrollment of Iliac Cohort in AGILITY IDE Study of Revello Covered Stent

November 4, 2025— BD announced full enrollment of the iliac artery patient cohort in its pivotal AGILITY investigational device exemption (IDE) study, which is evaluating the Revello vascular covered stent for the treatment of peripheral artery disease (PAD).

The enrollment milestone announcement was made in conjunction with a late-breaking clinical trial presentation at VIVA25 by Sean Lyden, MD, Chairman of the Department of Vascular Surgery at Cleveland Clinic and Global Lead Principal Investigator for the AGILITY study.

The IDE trial is designed as a prospective, multicenter study to assess the safety and effectiveness of the Revello self-expanding covered stent system in patients with de novo or restenotic PAD lesions. The trial includes two cohorts: the common and external iliac artery cohort (n = 118) (now fully enrolled) and the superficial femoral and proximal popliteal artery cohort (n = 223) (enrollment ongoing).

The AGILITY study (NCT06111469) is being conducted at up to 45 sites across the United States, Europe, Australia, and New Zealand.

According to BD, the Revello covered stent represents the company’s next generation in self-expanding stent technology, designed to enhance flexibility, deliverability, and conformability in treating complex PAD anatomy. The Revello stent system is not yet commercially available and remains under clinical investigation as part of the AGILITY IDE program.