BD reports nine-month AGILITY trial vascular stent results
- BD announced nine-month AGILITY trial results showing its Revello Vascular Covered Stent met the primary endpoint in iliac artery disease.
- Following the announcement regarding the vascular treatment results, the company's share price traded lower at $180.30.
- The company expects the trial data to support the continued clinical evaluation of the investigational device during its ongoing 36-month follow-up period.
BD (NYSE:BDX) announced nine-month AGILITY trial results showing its Revello Vascular Covered Stent met the primary endpoint with a 97.2% primary patency rate in iliac artery disease.
The combined safety and effectiveness endpoint recorded a 2.8% failure rate, which performed significantly below the prespecified 19% clinical goal.
The clinical study enrolled 120 patients across 28 trial sites to evaluate the treatment of target lesions.
The published trial data demonstrated a freedom from clinically driven repeat treatment rate of 98.3%, alongside a 31.7-point improvement in the mean walking impairment questionnaire score.
The manufacturer reported zero device-related deaths, target limb major amputations, or unanticipated serious adverse device effects during the nine-month period.
The Revello stent currently holds a CE mark but remains strictly limited to investigational use in the United States as follow-up evaluation continues through 36 months.
