AGILITY 9-Month Data Presented for BD’s Revello Vascular Covered Stent

October 8, 2026—BD (Becton, Dickinson and Company) announced 9-month results from the iliac cohort of the AGILITY investigational device exemption trial evaluating the company’s Revello vascular covered stent.

The study met its primary composite endpoint, demonstrating strong safety and effectiveness outcomes in patients with iliac artery disease, stated BD.

Sean Lyden, MD, who serves as Global Lead Principal Investigator for AGILITY, presented the data at VIVA 2026, the Vascular Interventional Advances conference.

According to the company, the AGILITY iliac cohort enrolled 120 patients at 28 investigational sites in the United States, Europe, Australia, and New Zealand. Women represented approximately 41% of enrolled patients, and more than half of lesions showed moderate-to-severe calcification.

As outlined in BD’s press release, results of treatment with the Revello vascular covered stent through 9 months of follow-up included:

• A failure rate of 2.8% in the composite safety and effectiveness endpoint, which is significantly below the 19% prespecified performance goal
• A primary patency rate of 97.2%
• Freedom from clinically driven target lesion revascularization of 98.3%
• No device- or procedure-related deaths; no target limb major amputations (at or above the ankle); no unanticipated serious adverse device effects

The company further advised that the study showed patients experienced meaningful gains in daily function and mobility, with mean Rutherford category improving from 3.0 at baseline to 0.3 and mean Walking Impairment Questionnaire score improving by 31.7 points from baseline to 9 months.

“These latest data showed high primary patency and low clinically driven target lesion revascularization in a patient population that included both straightforward and complex iliac lesions,” commented Dr. Lyden in BD’s press release. “Results showed the treated arteries remained open in a high percentage of patients, and at 9 months, patients also showed changes in disease severity and walking ability.” Dr. Lyden is Chairman of the Department of Vascular Surgery at Cleveland Clinic in Cleveland, Ohio.

BD stated that clinical follow-up in the iliac cohort is ongoing through 36 months. The company completed enrollment in the study’s superficial femoral and proximal popliteal artery cohort in August 2026, noted the press release.

In March 2026, BD announced European CE Mark approval for the Revello vascular covered stent for the treatment of atherosclerotic lesions in the common and external iliac arteries.

In the United States, Revello is an investigational device limited by federal law to investigational use only, noted the BD press release.