BD (Becton, Dickinson and Company), a prominent player in the global medical technology arena, has reached a significant milestone by acquiring CE Marking for its advanced Revello™ Vascular Covered Stent. This device is specifically designed to treat atherosclerotic lesions in the iliac arteries, addressing a critical need as peripheral artery disease (PAD) significantly burdens the aging population across the European Union (EU).
The Revello™ Stent represents an innovative leap forward in endovascular solutions. It adjudges to deliver both flexibility and strength, thanks to its combination of a nitinol self-expanding stent with a tailored radial resistive force, perfect for the unique requirements of the iliac arteries. Rima Alameddine, worldwide president of BD Interventional – Peripheral Intervention, emphasizes the stent's potential to set a new benchmark in the treatment of complex iliac artery disease.
"The launch of the Revello™ Stent is transformative for healthcare professionals who handle intricate cases of iliac artery ailments," Alameddine stated. He further noted that the stent is part of BD's strategy to enhance its peripheral vascular portfolio, continuing their commitment to delivering clinically relevant innovations.
Designed with a focus on patient safety, the Revello™ Stent features an ultra-thin expanded polytetrafluoroethylene (ePTFE) covering to maintain vessel patency and minimize the risk of trauma to healthy tissue. This is advantageous, particularly for patients who are vulnerable due to the complexities associated with PAD. Additionally, the stent comes integrated with tantalum radiopaque markers, allowing precise visualization during fluoroscopy for safer deployment, even in challenging anatomical scenarios.
The deployment system for the Revello™ Stent is tri-axial, which enhances control and accuracy during placement. This system includes specialized features such as an atraumatic tip for seamless insertion and an adjustable thumbwheel that grants clinicians intuitive control over stent handling. The Revello™ Stent is offered in an array of sizes, presenting more diameters within a lower profile that stands out in the European market, thus potentially minimizing access site complications.
Following the receipt of the CE Mark, BD introduced the Revello™ Stent at the LINC 2026 congress, a significant platform for vascular intervention showcasing in Germany. Dr. Michael Lichtenberg, a physician and angiologist, shared insights from the ongoing AGILITY clinical trial assessing the performance of the device among patients with PAD. This trial is steered by notable figures such as Dr. Sean Lyden from Cleveland Clinic, confirming the stent's promising potential in clinical practice.
Dr. Lichtenberg stated, "The Revello™ Stent offers a robust new alternative for iliac artery treatments, characterized by its superior radial force and low-profile design. The tri-axial delivery mechanism ensures precise placement, making it an excellent addition to our therapeutic arsenal."
The Revello™ Stent is set to launch in several EU countries that accept the CE mark, while it remains under investigation in the United States, constrained by local regulations. BD's proactive approach to enhancing treatment options for peripheral artery disease exemplifies its overarching goal to elevate health standards globally. With over 60,000 employees worldwide, BD is committed to fostering innovative solutions that not only improve patient outcomes but also optimize healthcare delivery systems on a global scale. Their dedication reinforces why healthcare professionals and patients alike are looking forward to the advancements BD is making in areas that most critically affect public health.
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