Becton, Dickinson Stent Shows Strong Nine-Month Results in Peripheral Artery Trial
Becton, Dickinson and Company (BDX) reported positive nine-month clinical trial results for its Revello Vascular Covered Stent. The study evaluated 120 patients with iliac artery disease across 28 international sites, meeting primary safety and effectiveness targets with a failure rate of just 2.8 percent, well under the 19 percent benchmark target. Treated arteries remained open in 97.2 percent of patients, while 98.3 percent did not require repeat procedures.
The results show improvements in disease severity and patient walking mobility without major complications or procedure-related deaths. While the device already holds European CE marking, it remains restricted to investigational use in the United States. Positive clinical data strengthens the company's position in the peripheral vascular market, which is expected to expand as demand for minimally invasive treatments grows.
Patients in the study will be tracked through 36 months to measure long-term durability. Meanwhile, enrollment for another clinical cohort examining additional vascular applications was completed earlier this year. Long-term commercial success will depend on extended trial outcomes and gaining United States regulatory approval.
Key points
- Becton, Dickinson and Company reported a 2.8 percent failure rate in a 120-patient trial for its Revello stent, easily surpassing the 19 percent target benchmark.
- Trial data demonstrated 97.2 percent primary artery openness and 98.3 percent freedom from repeat clinical procedures at nine months.
- The stent is CE-marked in Europe but remains under investigational status in the United States pending further regulatory progress.
- Study participants will be monitored for 36 months to assess the long-term durability and effectiveness of the device.
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What were the AGILITY trial results for Becton Dickinson?
The nine-month trial showed a 2.8 percent failure rate, 97.2 percent artery openness, and 98.3 percent freedom from repeat procedures, with no device-related deaths or major amputations.
Is the Revello stent approved in the United States?
No. While the Revello stent holds CE marking in Europe, it remains an investigational device in the United States and cannot be sold commercially without further regulatory clearance.
How long will trial patients be monitored in the Revello stent study?
Clinical follow-up for the iliac cohort of the AGILITY trial will continue through 36 months to verify the device's long-term durability and effectiveness.