BD Achieves Key Enrollment in AGILITY Study for Revello™ Stent
BD (Becton, Dickinson and Company) (NYSE: BDX), a key player in global medical technology, has reached a significant milestone with the full enrollment of the iliac artery patient group in its AGILITY Investigational Device Exemption (IDE) study. This important study is focused on evaluating the Revello™ Vascular Covered Stent for patients suffering from peripheral arterial disease (PAD).
Significance of the AGILITY Study
Presented at the VIVA (Vascular InterVentional Advances) 2025 conference by Dr. Sean Lyden, chairman of the Department of Vascular Surgery at the Cleveland Clinic and the global principal investigator, this study marks an essential phase in the research and development of advanced PAD treatments. The AGILITY study focuses on exploring the potential of the Revello™ Vascular Covered Stent, aiming to enhance treatment choices for both de novo and restenotic lesions.
Innovative Technology Addressing Clinical Needs
The AGILITY study signifies a commitment by BD to innovate within the field of endovascular care. Patients struggling with PAD require solutions that deliver both flexibility and effective performance. The newly developed Revello Stent is designed with these necessities in mind—offering improved deliverability and a low-profile design.
Full Enrollment of the Iliac Cohort
Dr. Lyden expressed the importance of reaching complete enrollment for the iliac cohort of the study, stating, "This milestone not only represents progress in our research but also holds promise for patients dealing with peripheral arterial disease. As we continue to understand PAD more deeply, the need for innovative solutions becomes crucially apparent."
Study Design and Patient Cohorts
The AGILITY study (NCT06111469) is set to take place across 45 investigational sites spanning the United States, Europe, Australia, and New Zealand. It includes two primary cohorts: the fully enrolled common and external iliac artery cohort, consisting of 118 participants, and the ongoing enrollment for the superficial femoral and proximal popliteal artery cohort, which includes 223 patients.
Commitment to Advancing Patient Outcomes
As JD Meler, MD, FSIR, vice president of BD Enterprise Pre-Clinical Strategy and Medical Innovation, states, "The Revello™ Vascular Covered Stent represents the next step in our evolutionary approach to improving endovascular therapies. Our goal is to empower clinicians to provide the best possible outcomes for patients."
Understanding Peripheral Arterial Disease
PAD is a widespread circulatory issue characterized by narrowed arteries that decrease blood flow to limbs. This condition can lead to severe complications such as limb loss if not addressed adequately. Affecting over 21 million Americans and more than 200 million individuals worldwide, the urgency for effective treatments cannot be overstated. Untreated PAD poses risks of strokes, heart attacks, and even loss of limbs.
About BD
BD stands among the largest medical technology companies globally, devoted to improving health through advances in medical discovery, diagnostics, and care delivery. With over 70,000 dedicated employees, BD focuses on providing innovative solutions that cater to the needs of healthcare heroes, supporting both clinical theories and the processes that enhance healthcare delivery. Collaborating closely with various stakeholders, BD aims to improve health outcomes, reduce costs, and increase access to high-quality healthcare solutions.
Frequently Asked Questions
What is the AGILITY study focused on?
The AGILITY study evaluates the Revello™ Vascular Covered Stent for patients with peripheral arterial disease, aiming to enhance treatment options.
How many patient cohorts are involved in the AGILITY study?
There are two primary cohorts: one for common and external iliac arteries, which is fully enrolled, and another for superficial femoral and proximal popliteal arteries that is still enrolling participants.
Why is this study important?
This study addresses a significant clinical need for flexible, effective treatment options for patients experiencing challenges due to peripheral artery disease.
What is the mission of BD?
BD's mission is to advance healthcare through innovative technologies and solutions that improve the delivery of medical care and enhance patient safety.
How does peripheral arterial disease affect individuals?
PAD reduces blood flow to limbs, causing pain and increasing risks of serious events, such as heart attacks, strokes, and potentially limb loss if untreated.
