BD reports positive nine‑month results from AGILITY trial of Revello iliac stent
Becton, Dickinson announced that the nine‑month interim analysis of the AGILITY investigational device exemption trial met its primary composite endpoint for the iliac artery cohort. The Revello Vascular Covered Stent showed a low failure rate and high vessel openness, with no deaths or major amputations reported. The study enrolled 120 patients across 28 sites in the U.S., Europe, Australia and New Zealand. Follow‑up will continue through 36 months and the device remains CE‑marked but investigational in the United States.
Why it matters
BD says the data strengthen the clinical evidence base for the Revello stent and support its continued development for peripheral artery disease. The results may improve the company’s growth outlook for its vascular platform, which could be reflected in future revenue expectations.
Key facts
- 1The primary composite endpoint was achieved with a failure rate of 2.8%, well under the 19% performance goal. news.bd.com
- 2Primary vessel patency at nine months was reported at 97.2%. news.bd.com
- 3Freedom from clinically driven target lesion revascularization was 98.3% at nine months. news.bd.com
- 4The iliac cohort enrolled 120 patients at 28 investigational sites. news.bd.com
- 5Women comprised roughly 41% of the enrolled population. news.bd.com
- 6Clinical follow‑up for the iliac cohort will continue through 36 months. news.bd.com
Summary written by AlphAI from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.