BD Enrolls First Patient in PAD Vascular Covered Stent Study

Becton, Dickinson and Company (BD) today announced it has enrolled its first patient in the Agility study to assess the safety and effectiveness of the BD Vascular Covered Stent for treatment of peripheral arterial disease (PAD). The patient was enrolled at Trinity Medical Center in Bettendof, IO.

PAD is the narrowing or blockage of the vessels that carry blood to the legs or lower extremities, according to the Centers for Disease Control and Prevention. Primarily caused by the buildup of fatty plaque in the arteries, called atherosclerosis, it can happen in any blood vessel but is more common in the legs than the arms. The disease can become debilitating, leading to an increased risk of cardiovascular complications and limb amputation.

In turn, use of minimally invasive procedures such as covered stents can be used to increase blood flow through the diseased areas. BD’s Vascular Covered stent, according to the company, is a self-expanding, low profile, polytetrafluoroethylene encapsulated nitinol implant that is deployed from a delivery system that provides controlled release.

“When we're addressing advanced PAD, a self-expanding covered stent can play an important role," said Dr. Sean Lyden, chairman of the Department of Vascular Surgery at Cleveland Clinic and national principal investigator of the Agility study, in the 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."

The investigational device exemption (IDE) study examining the covered device’s efficacy will be characterized as global, prospective, multi-center, single-arm, and non-randomized, according to BD. Covering 40 clinical study sites across the US, Europe, Australia, and New Zealand, the trial will enroll 315 patients that will be followed up with at various times post-procedure — starting at one month and ending at 36 months.

"There continues to be significant unmet needs in the treatment of PAD patients," said Tim Hug, vice president and general manager at BD Peripheral Intervention, in the release. "We are excited to have initiated this study and evaluate the treatment benefits of this potentially differentiated technology. This stent could give interventionalists an important new solution in the fight against PAD, expand our portfolio and enable us to better serve our customers and the patients they treat."