BD Achieves Milestone in AGILITY Study of Revello™ Vascular Covered Stent for Treatment of Peripheral Artery Disease

Rhea-AI Summary

BD (NYSE: BDX) announced on November 4, 2025 that the AGILITY IDE study has achieved full enrollment of the common and external iliac artery cohort (n=118) for the Revello™ Vascular Covered Stent in peripheral artery disease (PAD).

The multi-center, prospective AGILITY study (NCT06111469) is enrolling at up to 45 sites across the United States, Europe, Australia and New Zealand and includes a second cohort for superficial femoral and proximal popliteal arteries (n=223) with enrollment ongoing. The milestone was announced during a late-breaking presentation at VIVA 2025 by Dr. Sean Lyden.

Positive

• Iliac cohort fully enrolled at n=118
• Multi-center reach across up to 45 investigational sites
• Global enrollment in US, Europe, Australia, New Zealand
• Late-breaking presentation at VIVA 2025 increases visibility

Negative

• Femoral/popliteal cohort enrollment ongoing (n=223)
• No clinical outcome data or timing for readouts disclosed

Insights

Clinical Trial Strategist

Full enrollment of the iliac cohort advances a pivotal IDE study for BD's Revello™ covered stent and preserves regulatory pathway momentum.

BD reached full enrollment of the Common and external iliac artery cohort (n=118) in the AGILITY IDE study on Nov. 4, 2025, a meaningful operational milestone that keeps the trial on schedule and enables collection of planned safety and effectiveness data for that cohort. Completion of a cohort reduces execution risk for the study and supports a clearer dataset for regulatory review when the company compiles interim or final analyses.

Key dependencies remain: completion of enrollment in the Superficial femoral and proximal popliteal artery cohort (n=223), data quality across up to 45 sites, and subsequent follow-up and endpoint adjudication. Until the study reports prespecified endpoints, the clinical and regulatory implications remain conditional; enrollment alone does not demonstrate safety or efficacy.

Watch for trial milestones and timing of data readouts: enrollment completion for the second cohort and any interim or primary endpoint results, which are the next monitorable items. Expect these in the study's stated timelines as sites finish enrollment and patients reach required follow-up windows over the coming months to years.

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 Americans¹ and over 200 million people worldwide². Left untreated, it can lead to stroke, heart attack and even limb loss³.

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.

Contacts:
Media:	Investors:
Fallon McLoughlin	Adam Reiffe
Director, Public Relations	Sr. Director, Investor Relations
201.258.0361	201.847.6927
fallon.mcloughlin@bd.com	adam.reiffe@bd.com

 

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.

BD, the BD Logo, Advancing the world of health and Revello are trademarks of Becton, Dickinson and Company or its affiliates. © 2025 BD. All Rights Reserved. BD-164110

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SOURCE BD (Becton, Dickinson and Company)

FAQ

What milestone did BD (BDX) announce for the AGILITY study on November 4, 2025?

BD announced full enrollment of the common and external iliac artery cohort (n=118) for the AGILITY IDE study.

What is the size and status of the superficial femoral and proximal popliteal cohort in AGILITY (BDX)?

That cohort is planned at n=223 and enrollment is currently ongoing.

How many sites and regions are participating in BD's AGILITY study (NCT06111469)?

AGILITY is conducted at up to 45 investigational sites across the United States, Europe, Australia and New Zealand.

What device is being evaluated in the AGILITY IDE study by BD (BDX)?

The study evaluates the Revello™ Vascular Covered Stent for treatment of de novo or restenotic PAD lesions.

When and where was BD's AGILITY enrollment milestone presented?

The milestone was presented as a late-breaking clinical trial presentation at VIVA 2025 by Dr. Sean Lyden.

Does the AGILITY announcement include clinical outcome data or readout timing for BD (BDX)?

No; the announcement confirms cohort enrollment but does not provide clinical outcome data or readout dates.