Global Finance News
07 Oct 2026, 17:08
BD Reports Positive AGILITY Trial Results for Revello Covered Stent in Iliac Artery Disease
BD (Becton, Dickinson and Company) (NYSE: BDX) announced positive nine-month results from the iliac cohort of its ongoing AGILITY trial evaluating the Revello Vascular Covered Stent in patients with iliac artery disease.
The study met its primary composite safety and effectiveness endpoint, with a failure rate of 2.8%, well below the prespecified performance goal of 19%. Primary patency reached 97.2%, while 98.3% of patients remained free from clinically driven target lesion revascularization through nine months.
BD also reported no device- or procedure-related deaths, no major target-limb amputations at or above the ankle, and no unanticipated serious adverse device effects.
The AGILITY iliac cohort enrolled 120 patients across 28 investigational sites in the U.S., Europe, Australia and New Zealand. Patients also showed meaningful functional improvement, with the mean Rutherford category improving from 3.0 at baseline to 0.3 and the Walking Impairment Questionnaire score increasing by 31.7 points.
The Revello device combines a self-expanding nitinol stent with radial support designed for the iliac arteries. BD said the findings support continued evaluation of the system in both straightforward and more complex iliac lesions.
Follow-up in the iliac cohort will continue through 36 months. The Revello Vascular Covered Stent is CE marked but remains investigational in the United States.
BD (Becton, Dickinson and Company) (NYSE: BDX) announced positive nine-month results from the iliac cohort of its ongoing AGILITY trial evaluating the Revello Vascular Covered Stent in patients with iliac artery disease.
The study met its primary composite safety and effectiveness endpoint, with a failure rate of 2.8%, well below the prespecified performance goal of 19%. Primary patency reached 97.2%, while 98.3% of patients remained free from clinically driven target lesion revascularization through nine months.
BD also reported no device- or procedure-related deaths, no major target-limb amputations at or above the ankle, and no unanticipated serious adverse device effects.
The AGILITY iliac cohort enrolled 120 patients across 28 investigational sites in the U.S., Europe, Australia and New Zealand. Patients also showed meaningful functional improvement, with the mean Rutherford category improving from 3.0 at baseline to 0.3 and the Walking Impairment Questionnaire score increasing by 31.7 points.
The Revello device combines a self-expanding nitinol stent with radial support designed for the iliac arteries. BD said the findings support continued evaluation of the system in both straightforward and more complex iliac lesions.
Follow-up in the iliac cohort will continue through 36 months. The Revello Vascular Covered Stent is CE marked but remains investigational in the United States.
