FRANKLIN LAKES, N.J. , Nov. 4, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced full enrollment of the iliac artery patient cohort in its pivotal AGILITY Investigational Device Exemption (IDE) study, a prospective, multi-center study evaluating the Revello™ Vascular Covered Stent in patients with peripheral arterial disease (PAD).

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.

The AGILITY study represents the latest advancement by BD in self-expanding covered stent technology, aiming to address the clinical need for improved flexibility, deliverability and low-profile performance in the treatment of challenging PAD lesions.

"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."

The AGILITY study (NCT06111469) is being conducted in up to 45 investigational sites in the United States , Europe , Australia and New Zealand . It aims to evaluate the safety and effectiveness of the Revello™ Vascular Covered Stent for the treatment of de novo or restenotic lesions in two patient cohorts:

• Common and external iliac artery cohort (n=118) – now fully enrolled; and
• Superficial femoral and proximal popliteal artery cohort (n=223) – enrollment ongoing.

"This milestone reinforces the commitment of BD to advancing clinically meaningful innovation in endovascular care," said JD Meler, MD, FSIR, vice president 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."

About Peripheral Arterial Disease

PAD is a common circulatory problem in which narrowed arteries reduce blood flow to the limbs, often causing pain and increasing the risk of serious complications such as limb loss. The disorder affects more than 21 million Americans 1 and over 200 million people worldwide 2 . Left untreated, it can lead to stroke, heart attack and even limb loss 3 .

About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health ™ by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiency, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ , X (formerly Twitter) at @BDandCo or Instagram at @becton_dickinson .

1 Yost M. The current U.S. prevalence of peripheral arterial disease.  Vasc Dis Manag . 2023;20(4):E67-E73.
2 Allison MA, Armstrong DG, Goodney PP, et al. Health disparities in peripheral artery disease: A scientific statement from the American Heart Association.  Circulation . 2023;148(3):286-296. doi:10.1161/CIR.0000000000001153
3 Criqui MH, Matsushita K, Aboyans V, et al. Lower Extremity Peripheral Artery Disease: Contemporary Epidemiology, Management Gaps, and Future Directions: A Scientific Statement From the American Heart Association.  Circulation . 2021;144(9):e171–e191.

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