BD (NYSE: BDX) today announced that it completed enrollment in the iliac artery patient cohort in its pivotal AGILITY study.
AGILITY, an FDA investigational device exemption (IDE) study, evaluates the Revello vascular covered stent in patients with peripheral arterial disease (PAD). Franklin Lakes, New Jersey–based BD initiated the trial earlier this year. It announced the completed enrollment in conjunction with a presentation at the VIVA (Vascular Interventional Advances) 2025 Conference in Las Vegas.
The self-expanding, low-profile, polytetrafluoroethylene encapsulated nitinol Revello implant is deployed through a delivery system. This system provides controlled stent release to treat PAD.
AGILITY represents the latest advancement by BD in self-expanding covered stent technology, the company says. It aims to address the need for improved flexibility, deliverability and low-profile performance in the treatment of challenging PAD lesions.
Investigators are conducting AGILITY across 45 sites in the U.S., Europe, Australia and New Zealand. It evaluates Revello’s safety and effectiveness in de novo or restenotic lesions in two patient cohorts. One cohort, evaluating common and external iliac arteries, achieved full enrollment at 118 patients. The other — the superficial femoral and proximal popliteal artery cohort — has enrollment ongoing at 223 patients.
“This milestone reinforces the commitment of BD to advancing clinically meaningful innovation in endovascular care. The Revello vascular covered stent is our next generation system, designed to support physicians and help optimize outcomes for patients,” said Dr. JD Meler, VP of BD Enterprise Pre-Clinical Strategy and Medical Innovation.
