BD's AGILITY Trial Milestone and Its Implications for Endovascular Innovation

The recent completion of enrollment in the common and external iliac artery cohort of BD's AGILITY Investigational Device Exemption (IDE) study marks a pivotal step in the development of the Revello™ Vascular Covered Stent. As of November 4, 2025, the first cohort (n=118) has been fully enrolled, reducing execution risk and providing a clearer dataset for regulatory review, according to a StockTitan article. This milestone underscores BD's strategic progress in advancing endovascular innovation, particularly in addressing the unmet clinical needs of patients with peripheral artery disease (PAD).

Strategic Design Innovations and Market Positioning

The Revello stent is engineered to overcome limitations of existing devices, such as the Wallstent and Viabahn, by enhancing flexibility, deliverability, and low-profile performance. These design features aim to improve outcomes in treating complex PAD lesions, a market segment projected to grow significantly. The global covered stent market, valued at $3.5 billion in 2024, is expected to expand at a compound annual growth rate (CAGR) of 6.2%, reaching $5.8 billion by 2033, per an InsightClimb analysis. BD's focus on next-generation technology positions it to capture a larger share of this expanding market, particularly as competitors like W.L. Gore & Associates (Viabahn) and Boston Scientific (Wallstent) face increasing pressure to innovate.

Regulatory Pathway and Clinical Validation

The AGILITY trial, a multi-center, prospective study conducted across 45 sites in the U.S., Europe, Australia, and New Zealand, is structured to evaluate the stent's safety and effectiveness in two cohorts: iliac arteries and superficial femoral/proximal popliteal arteries. While the first cohort's enrollment completion is a critical operational win, regulatory approval hinges on prespecified endpoints, including primary patency and freedom from major adverse events. For the iliac cohort, the primary endpoint is a composite measure assessed at 9 months, while the femoral/popliteal cohort will be evaluated at 12 months.

Investors should note that enrollment alone does not guarantee regulatory success. The trial's non-randomized, single-arm design may require robust comparative data to satisfy regulators. However, BD's emphasis on data quality and endpoint adjudication-key dependencies for the study-positions the company to navigate these challenges, as noted in the StockTitan article.

Comparative Landscape and Clinical Evidence

While direct head-to-head data between the Revello stent and existing devices like the Wallstent or Viabahn remains limited, indirect comparisons offer insights. The ARMADILLO study, for instance, found comparable 1-year primary patency rates between covered stent-grafts (e.g., Wallstent) and interwoven nitinol stents (e.g., Supera) in calcified femoropopliteal lesions. Such findings suggest that design innovations, rather than incremental improvements, will drive differentiation in the market. BD's Revello stent, with its focus on low-profile delivery and enhanced conformability, aligns with this trend.

Conclusion: Balancing Momentum and Uncertainty

BD's AGILITY trial milestone reflects strong execution in a high-stakes regulatory environment. However, the path to approval remains contingent on the second cohort's enrollment and the robustness of endpoint data. For investors, the Revello stent represents a strategic bet on endovascular innovation, with potential to redefine treatment paradigms for PAD. As the trial progresses, BD's ability to demonstrate superior clinical outcomes relative to existing devices will be critical in solidifying its market position and justifying long-term investment.