BD (Becton, Dickinson and Company) has started an initiative aimed at advancing treatment options for patients suffering from Peripheral Arterial Disease (PAD). This project marks the beginning of enrollment for the investigational device exemption (IDE) study named “AGILITY.” The primary focus of this study is to evaluate the safety and efficacy of the BD Vascular Covered Stent in the management of PAD. PAD, affecting over 18 million Americans and more than 236 million individuals worldwide, is a debilitating condition characterized by the narrowing of arteries in the legs, often leading to severe cardiovascular complications and limb amputation. The beginning of the AGILITY study marks a step forward in addressing the unmet clinical needs of PAD patients.
The BD Vascular Covered Stent is an advancement in interventional cardiology. Crafted from nitinol and encapsulated with polytetrafluoroethylene, this stent offers many advantages. Its self-expanding design allows for precise deployment, ensuring optimal positioning within the affected artery. The stent’s low profile minimizes the risk of vascular trauma during insertion and promotes enhanced patient comfort post-procedure. The fluoropolymer coating provides a durable barrier against restenosis and thrombosis, addressing common challenges encountered in the treatment of PAD. Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and National Principal Investigator of the AGILITY study, outlines the importance of such technology in addressing advanced PAD. The stent’s ability to accurately navigate to the lesion, conform closely to the vessel wall, and provide long-term durability holds huge potential for improving clinical outcomes and enhancing the quality of life for PAD patients worldwide.
The AGILITY study aims to enroll 315 patients across multiple clinical study sites located in the United States, Europe, Australia, and New Zealand. This prospective, multicenter, single-arm, non-randomized trial is designed to provide insights into the safety and efficacy profile of the BD Vascular Covered Stent. Follow-up assessments, spanning up to 36 months post-treatment, will be conducted to evaluate the long-term performance and durability of the stent. The enrollment of the first patient at Trinity Medical Center in Bettendorf, Iowa, under the guidance of Dr. Nicolas Shammas, signifies a milestone in this groundbreaking research project.
Stephanie Klocke, Vice President of R&D, Peripheral Intervention at BD, outlines the transformative potential of the investigational stent during a recent webcast on PAD. She describes the device as an exciting advancement for both physicians and patients, emphasizing its role as a valuable addition to the treatment options for PAD. Klocke’s insights shed light on the importance of BD’s commitment to innovation in peripheral vascular disease. BD’s diverse product portfolio shows its dedication to addressing the evolving clinical needs of PAD patients and healthcare professionals.
BD’s focus on peripheral vascular disease is further outlined by its range of product offerings, which include the Rotarex atherectomy system and a diverse venous portfolio. By leveraging its expertise and resources in this therapeutic area, BD aims to address the needs of patients with PAD and empower healthcare professionals with advanced treatment modalities. With the AGILITY study underway, BD remains at the forefront of research projects aimed at improving the lives of individuals affected by PAD, ultimately redefining the standards of care in vascular medicine.
