Becton, Dickinson and Company (BD) has reported nine-month clinical findings from the iliac cohort of its AGILITY Investigational Device Exemption trial of the Revello Vascular Covered Stent.
AGILITY global lead principal investigator Sean Lyden, presented the findings at the VIVA 2026 conference.
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The data showed that the trial achieved its primary composite safety and effectiveness endpoint in individuals with iliac artery disease, a common form of peripheral artery disease.
The clinical study recorded a 2.8% failure rate for the primary composite safety and effectiveness endpoint, remaining below the prespecified performance goal of 19%.
Primary patency reached 97.2%, whilst freedom from clinically driven target lesion revascularisation was 98.3% over the nine-month period.
Investigators documented no device- or procedure-related deaths, target limb major amputations at or above the ankle, or unanticipated serious adverse device effects.
The trial’s iliac arm enrolled 120 patients across 28 investigative sites located in Australia, Europe, New Zealand, and the US.
Female participants comprised around 41% of the cohort, and moderate-to-severe calcification affected slightly more than half of the treated lesions.
Patients demonstrated functional gains over the study period, with the mean Rutherford category improving from 3.0 at baseline to 0.3 at nine months, alongside a 31.7-point average improvement in the Walking Impairment Questionnaire score.
BD vascular platform, peripheral intervention vice-president and general manager Rob Righi said: “These results reflect the continued commitment of BD to advance evidence-based innovation in peripheral vascular care.
“As follow-up continues, the AGILITY study will help further characterise the Revello Vascular Covered Stent’s performance across patients with peripheral artery disease.”
Engineered for iliac artery disease, which can impair mobility and cause leg pain or cramping, the Revello Vascular Covered Stent combines a flexible nitinol self-expanding framework with radial resistive force.
Clinical monitoring for the iliac cohort will continue through 36 months, following the enrolment completion in the trial’s superficial femoral and proximal popliteal artery cohort this past August.
The stent holds CE mark approval in Europe, whilst in the US it remains limited by federal law to investigational use.
In August this year, BD completed patient enrolment in the PREVENT clinical trial, which is evaluating the use of Phasix Mesh for preventing incisional hernias.
