BD achieved full enrollment of 118 patients in the iliac artery arm of the AGILITY Investigational Device Exemption study for its Revello Vascular Covered Stent, a self‑expanding, low‑profile, polytetrafluoroethylene‑covered nitinol device.
The AGILITY study is a prospective, multi‑center trial conducted across 45 sites in the United States, Europe, Australia, and New Zealand. It began enrolling patients on March 4 2024 and plans to enroll 315 patients across up to 40 sites, with the second cohort—targeting superficial femoral and proximal popliteal arteries—ongoing at 223 patients.
Full enrollment of the iliac cohort keeps the trial on schedule for planned safety and effectiveness analyses and regulatory submissions, advancing BD’s path toward FDA approval and market entry for the Revello stent.
The milestone was highlighted during a late‑breaking presentation at the VIVA 2025 conference by Dr. Sean Lyden. The Revello stent’s design addresses the growing peripheral arterial disease market, projected to reach $6.11 billion by 2034, underscoring BD’s commitment to expanding its vascular portfolio and delivering innovative solutions for PAD.
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