BD Strengthens Its Position in Peripheral Vascular Innovation with Promising AGILITY Trial Outcomes

In a significant advancement for the treatment of peripheral artery disease (PAD), BD (Becton, Dickinson and Company) has released positive findings from its AGILITY trial focused on the Revello™ Vascular Covered Stent. As noted in the findings presented at VIVA 2026, the results reveal promising safety and efficacy metrics that may transform patient care for those suffering from complex iliac artery diseases.

The AGILITY trial is an ongoing study expected to span 36 months, evaluating significant outcomes over nine months for patients diagnosed with iliac artery disease, a prevalent condition under the umbrella of PAD. The data, which was showcased by Sean Lyden, M.D., the global lead principal investigator, indicates a 97.2% primary patency rate and an impressive 98.3% freedom from clinically driven target lesion revascularization, far exceeding the study's predefined performance goal of 19%.

This groundbreaking device under study, the Revello™ Vascular Covered Stent, is engineered to offer greater flexibility through its nitinol self-expanding structure and is strategically designed for the unique anatomical challenges of the iliac arteries. Such innovation is crucial because iliac artery disease can drastically limit blood flow to the lower extremities, leading to symptoms like leg pain and cramping, which can significantly impair mobility and overall quality of life.

The AGILITY study enrolled 120 participants from 28 investigational sites across the United States, Europe, Australia, and New Zealand. Remarkably, within just nine months, patients experienced notable enhancements in their daily functionality and mobility. The mean Rutherford score, an indicator of disease severity, dropped from 3.0 at baseline to 0.3, while the Walking Impairment Questionnaire (WIQ) score markedly improved by an average of 31.7 points, suggesting a substantial uptick in patient quality of life.

The data presented confirmed critical safety measures, noting zero device- or procedure-related deaths, no major amputations above the ankle, and an exceedingly low failure rate of 2.8%. Dr. Lyden remarked on the significance of these results: “The high primary patency and low reintervention rates observed indicate not only the device's effectiveness but also highlight an urgent need for durable solutions in the treatment of both straightforward and complex iliac lesions.”

BD's commitment to persistent research and advancement in the field of vascular care is underscored by Rob Righi, the vice president and general manager of the Vascular Platform at BD. “These promising results reinforce our dedication to fostering evidence-based innovations that address the critical needs of patients suffering from PAD while also enabling healthcare providers to deliver improved patient outcomes.”

As the follow-up period continues to 36 months, the AGILITY trial will provide further insights into the long-term efficacy of the Revello™ Vascular Covered Stent, with ongoing evaluations anticipated in other cohorts focusing on the superficial femoral and proximal popliteal arteries.

The Revello™ Vascular Covered Stent has already obtained CE marking for use in Europe and is classified as an investigational device in the United States, limited to investigational use only under U.S. law.

About BD

BD is one of the largest pure-play medical technology companies worldwide, earning a reputation for advancing healthcare through innovative solutions across various domains including medical essentials, connected care, biopharma systems, and interventional technologies. With a workforce exceeding 60,000 employees globally, BD is dedicated to enhancing clinical operations and patient care through the development of transformative technologies and services. Explore more about BD's commitment and innovations by visiting bd.com or following them on LinkedIn, Twitter, and Instagram.