BD to Initiate Real-World Patient Data Registry for the Rotarex™ Atherectomy System in Treatment of Peripheral Artery Disease
Rhea-AI Summary
BD (NYSE: BDX) has announced the initiation of XTRACT, a patient data registry to evaluate real-world outcomes of its Rotarex™ Atherectomy System in treating peripheral artery disease (PAD). The registry will enroll up to 600 patients across approximately 100 clinical sites in the United States, with patient follow-ups at 30 days, 6 months, and 12 months post-procedure.
The Rotarex™ System is a minimally invasive device designed to remove both plaque and thrombus in peripheral arteries, serving as both an atherectomy and thrombectomy device. The study, led by Dr. Prakash Krishnan and Dr. Todd Berland, aims to assess the system's clinical performance in treating PAD, a condition affecting over 21 million Americans and 200 million people worldwide.
Positive
- First comprehensive registry study for Rotarex™ System in the US, demonstrating commitment to evidence-based research
- Large-scale study involving 600 patients across 100 clinical sites
- Dual functionality of the device as both atherectomy and thrombectomy tool
- Addresses a significant market with PAD affecting 21M+ Americans
Negative
- Results and potential benefits won't be known until study completion in over 12 months
- Significant resource investment required for large-scale registry study
News Market Reaction – BDX
In the trading session that priced this news, BDX declined 0.86%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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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
"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
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.
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1 Yost, Mary. The Current
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)