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BD to Initiate Real-World Patient Data Registry for the Rotarex™ Atherectomy System in Treatment of Peripheral Artery Disease
Prnewswire· 2025-05-28 10:50
Core Insights - BD (Becton, Dickinson and Company) is initiating a patient data registry for the Rotarex™ Atherectomy System to evaluate real-world outcomes for patients with peripheral artery disease (PAD) [1][2]. Group 1: Registry Details - The registry, named "XTRACT," is a prospective, multi-center, single-arm, post-market study aimed at assessing the clinical performance of the Rotarex™ Atherectomy System in treating U.S. patients with PAD lesions [3]. - The XTRACT Registry will enroll up to 600 patients across approximately 100 clinical sites in the United States, with the first patient expected to be enrolled later this year [3]. - Clinical follow-up evaluations will be conducted at 30 days, 6 months, and 12 months post-procedure to assess safety and effectiveness [3]. Group 2: Clinical Significance - The registry aims to provide valuable data to support clinical decision-making and enhance patient outcomes in managing PAD [4]. - The Rotarex™ Atherectomy System is designed to efficiently remove plaque and thrombus in peripheral arteries, serving dual purposes as both an atherectomy and thrombectomy device [4]. - The XTRACT Registry is the first comprehensive registry focused on real-world applications of the Rotarex™ System, highlighting BD's commitment to optimizing treatment strategies in collaboration with leading physicians [5]. Group 3: Industry Context - PAD affects over 21 million Americans and more than 200 million people globally, posing risks of cardiovascular complications and lower limb amputation [5]. - BD's initiative reflects its ongoing commitment to innovative technological development and evidence-based research to support physicians and improve patient outcomes [5].