BD reports nine-month AGILITY trial data for Revello stent
Becton, Dickinson and Company (BD) reported nine-month data from the AGILITY trial of its Revello Vascular Covered Stent, showing a 2.8% failure rate for the primary endpoint in iliac artery disease patients. The trial met its safety and effectiveness goals, with 97.2% primary patency and 98.3% freedom from revascularization. The stent is CE-marked in Europe but remains investigational in the US. BD aims to further characterize the stent's performance as follow-up continues.
How this was made

The 30-second read
Why it matters
The nine‑month results demonstrate safety and efficacy, potentially accelerating regulatory discussions and market adoption.
Market read
First disclosure of positive trial data could boost BD's stock and influence the peripheral vascular device sector.
What to watch
The trial size (120 patients) is modest; longer‑term 36‑month data will be needed to confirm durability.
Background
BD's Revello Vascular Covered Stent is currently CE‑marked in Europe and remains investigational in the US. The AGILITY trial is a pivotal IDE study.
Ticker impact
BD reported nine‑month AGILITY trial data for its Revello Vascular Covered Stent, showing 97.2% primary patency and low failure rates.
potential upside as market prices in the favorable safety and efficacy data
First‑time disclosure of robust nine‑month data reduces clinical risk perception and could support higher valuation for the Revello stent.
Market effects
Strengthens the peripheral vascular device segment and may benefit peers with similar product pipelines.
Data from multi‑regional sites (US, Europe, Australia, NZ) underscores global applicability.
Adds a positive data point to the broader medical device market, especially for companies pursuing FDA clearance.
Counterpoint
Investors may remain cautious until FDA approval is secured, as the device is still investigational in the US.
Key entities
- companyBecton, Dickinson and Company
US‑listed medical device manufacturer (ticker BDX).
- productRevello Vascular Covered Stent
Nitinol self‑expanding stent for iliac artery disease.



