BD’s AGILITY Study of Vascular Covered Stent Begins Enrollment

March 4, 2024—BD (Becton, Dickinson and Company) announced the enrollment of the first patient in the AGILITY investigational device exemption study, which will assess the safety and effectiveness of the company’s vascular covered stent for the treatment of peripheral artery disease (PAD).

The investigational vascular covered stent is a self-expanding, low-profile, polytetrafluoroethylene-encapsulated nitinol implant. It is deployed from a delivery system that provides controlled stent release.

According to BD, AGILITY is a global, prospective, multicenter, single-arm, nonrandomized clinical study that will enroll 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 1 month and ending at 36 months, stated BD.

The first patient in the study was enrolled by interventional cardiologist Nicolas Shammas, MD, at Trinity Medical Center in Bettendorf, Iowa.

The national Principal Investigator of the AGILITY study is Sean Lyden, MD, Chairman of the Department of Vascular Surgery at Cleveland Clinic in Cleveland, Ohio.

“When we’re addressing advanced PAD, a self-expanding covered stent can play an important role,” commented Dr. Lyden in BD’s press release. “We need a stent that can track to the lesion, apposes the vessel wall, and ultimately provides long-term durability. We’re excited to see how this technology performs.”