#None #Franklin Lakes #Becton Dickinson #Peripheral Artery Disease #Revello Stent

BD Achieves Significant Milestone in AGILITY Study

On November 4, 2025, BD (Becton, Dickinson and Company), one of the forefront companies in global medical technology, publicly announced that it has completed the enrollment process for the iliac artery patient group in its pivotal AGILITY Investigational Device Exemption (IDE) study. This multi-center, prospective study examines the effectiveness of the Revello™ Vascular Covered Stent, specifically designed for individuals suffering from Peripheral Artery Disease (PAD).

The news broke during a late-phase clinical trial presentation given by Dr. Sean Lyden, who serves as the chairman of the Department of Vascular Surgery at Cleveland Clinic, and acts as the global lead principal investigator of the AGILITY study. The study focuses on innovative self-expanding covered stent technology, which is engineered to meet the clinical demands for flexibility, deliverability, and low-profile performance, particularly in the treatment of challenging PAD lesions.

Dr. Lyden noted, “Reaching full enrollment in the iliac cohort is a significant milestone for both the AGILITY study and for patients living with peripheral arterial disease. With our growing knowledge about PAD, the need for innovative technologies that enhance treatment options becomes ever more urgent.”

The AGILITY study (NCT06111469) spans approximately 45 investigational sites across the United States, Europe, Australia, and New Zealand. Its goal is to evaluate the safety and effectiveness of the Revello™ Vascular Covered Stent for treating both de novo and restenotic lesions within two distinct patient cohorts:

• - The first cohort includes those with common and external iliac artery issues (n=118), which has now completed enrollment.
• - The second cohort focuses on patients with superficial femoral and proximal popliteal artery complications (n=223), which is still in the enrollment phase.

JD Meler, MD, FSIR, who is the vice president of BD Enterprise Pre-Clinical Strategy and Medical Innovation, expressed that this milestone reaffirms BD's dedication to fostering clinically meaningful innovations in endovascular care. “The Revello™ Vascular Covered Stent represents our next-generation system, meticulously developed to aid physicians and enhance patient outcomes.”

Understanding Peripheral Artery Disease (PAD)

Peripheral Artery Disease is a widespread circulatory condition characterized by narrowed arteries that diminish blood flow to the limbs, which can result in pain and increase the risk of severe complications, including limb loss. More than 21 million Americans and over 200 million individuals globally are affected by this condition. Without proper treatment, PAD can lead to catastrophic health issues such as stroke and heart attack, as well as the loss of limbs.

BD solidifies its position as one of the world's predominant medical technology firms by advancing health through innovations not only in discovery and diagnostics but also in effective delivery care. The company is devoted to supporting those on the healthcare frontline through the development of groundbreaking technologies and solutions that enhance both clinical therapies for patients and processes for healthcare providers.

With over 70,000 employees dedicated to this mission, BD's efforts extend across nearly every nation, collaborating with entities worldwide to tackle some of the most pressing global health challenges. By partnering closely with customers, BD aims to improve outcomes, reduce costs, increase efficiency, and enhance the safety and accessibility of healthcare services.

To explore more about BD and its continued efforts in advancing the realm of health, visit their website at bd.com or connect on platforms such as LinkedIn (@BDandCo), X (formerly Twitter), or Instagram (@becton_dickinson).