March 5, 2024- BD announced the enrollment of the first patient in the investigational device exemption (IDE) study, “AGILITY,” which will assess the safety and effectiveness of the BD Vascular Covered Stent for the treatment of Peripheral Arterial Disease (PAD). The investigational Vascular Covered Stent is a self-expanding, polytetrafluoroethylene encapsulated nitinol implant. It is deployed from a delivery system that provides controlled stent release.
PAD affects more than 18 million Americans and more than 236 million people worldwide.
According to BD, the randomized AGILITY clinical study will include 315 patients at up to 40 clinical study sites across the United States, Europe, Australia and New Zealand. Follow-up for all treated patients will be performed at various points after treatment — starting at one month and ending at 36 months.