BD to Initiate Real-World Patient Data Registry for the Rotarex™ Atherectomy System in Treatment of Peripheral Artery Disease

FRANKLIN LAKES, N.J., May 28, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE:BDX), a leading global medical technology company, today announced plans to initiate a patient data registry for the Rotarex™ Atherectomy System to measure real-world outcomes for patients with peripheral artery disease (PAD).

Known as "XTRACT," this prospective, multi-center, single-arm, post-market registry study will assess the clinical performance of the Rotarex™ Atherectomy System in the treatment of U.S. patients with PAD lesions. The XTRACT Registry is being led in partnership with Co-Principal Investigators, Dr. Prakash Krishnan, an interventional cardiologist, and Dr. Todd Berland, a vascular surgeon. The registry will enroll up to 600 patients at approximately 100 clinical sites across the United States, with the first patient enrollment expected later this year. Clinical follow-up evaluations will occur after 30 days, 6 months and 12 months post-procedure to assess safety and effectiveness of outcomes.

"This registry will provide valuable data to support clinical decision-making and enhance patient outcomes in the management of PAD," said Dr. Krishnan. "The Rotarex™ System has been extensively studied internationally, and we are excited to further evaluate its adaptability in treating a wide range of PAD lesions within the U.S. patient population."

The Rotarex™ Atherectomy System is a minimally invasive solution designed to efficiently remove both plaque and thrombus in peripheral arteries. Offering dual indications as both an atherectomy and thrombectomy device, the Rotarex™ Atherectomy System is a proven tool for treating PAD.

"The XTRACT Registry is the first comprehensive registry aimed at providing key insights into the real-world applications of the Rotarex™ System," said Rima Alameddine, worldwide president of BD Interventional-Peripheral Intervention. "This study underscores our unwavering commitment to optimizing treatment strategies in partnership with leading physicians to improve patient care."

PAD is a potentially debilitating disease that is estimated to affect more than 21 million Americans and more than 200 million people worldwide and can lead to increased risk of cardiovascular complications and lower limb amputation.^1,2 The XTRACT Registry underscores BD's ongoing commitment to innovative technological development and evidence-based research that support physicians and improve patient outcomes. 

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson. 

¹ Yost, Mary. The Current U.S. Prevalence of Peripheral Arterial Disease. Vascular Disease Management. 2023;20(4):E67-E73

² Allison MA, Armstrong DG, Goodney PP, et al. Health Disparities in Peripheral Artery Disease: A Scientific Statement From the American Heart Association. Circulation. 2023;148:286-296. doi:10.1161/CIR.0000000000001153

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SOURCE BD (Becton, Dickinson and Company)