BD Launches XTRACT Registry to Evaluate Real-World Outcomes of Rotarex Atherectomy System in Peripheral Artery Disease
核心洞察
BD (搜索) announced the initiation of the XTRACT Registry, a prospective multi-center study to assess real-world clinical performance of the Rotarex™ Atherectomy System (搜索) in treating U.S. patients with peripheral artery disease (搜索).
The registry will enroll up to 600 patients at approximately 100 clinical sites across the United States, with clinical follow-up evaluations at 30 days, 6 months, and 12 months post-procedure.
Peripheral artery disease (搜索) affects more than 21 million Americans and 200 million people worldwide, potentially leading to cardiovascular complications (搜索) and lower limb amputation.
BD (搜索) (Becton, Dickinson and Company) announced plans to initiate a comprehensive patient data registry for the Rotarex™ Atherectomy System (搜索) to measure real-world outcomes for patients with peripheral artery disease (搜索) (PAD (搜索)). The announcement represents the first comprehensive registry study aimed at providing key insights into the real-world applications of the Rotarex™ System in the United States.
XTRACT Registry Design and Scope
The XTRACT Registry is designed as a prospective, multi-center, single-arm, post-market registry study that will assess the clinical performance of the Rotarex™ Atherectomy System (搜索) in treating U.S. patients with PAD (搜索) lesions. The study will enroll up to 600 patients at approximately 100 clinical sites across the United States, with the first patient enrollment expected later this year.
The registry is being led in partnership with Co-Principal Investigators Dr. Prakash Krishnan, an interventional cardiologist, and Dr. Todd Berland, a vascular surgeon. 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 (搜索)," 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."
Technology and Clinical Applications
The Rotarex™ Atherectomy System (搜索) is a minimally invasive solution designed to efficiently remove both plaque and thrombus in peripheral arteries (搜索). The device offers dual indications as both an atherectomy and thrombectomy device, positioning it as a proven tool for treating PAD (搜索).
"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 (搜索) Interventional-Peripheral Intervention. "This study underscores our unwavering commitment to optimizing treatment strategies in partnership with leading physicians to improve patient care."
Disease Burden and Clinical Need
PAD (搜索) is a potentially debilitating disease that is estimated to affect more than 21 million Americans and more than 200 million people worldwide. The condition can lead to increased risk of cardiovascular complications (搜索) and lower limb amputation, highlighting the significant unmet medical need for effective treatment options.
The XTRACT Registry underscores BD (搜索)'s ongoing commitment to innovative technological development and evidence-based research that support physicians and improve patient outcomes in this challenging therapeutic area.