BD (Becton, Dickinson and Company) announced plans to initiate a comprehensive patient data registry for the Rotarex™ Atherectomy System to measure real-world outcomes for patients with peripheral artery disease (PAD). 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 in treating U.S. patients with PAD 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," 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 is a minimally invasive solution designed to efficiently remove both plaque and thrombus in peripheral arteries. The device offers dual indications as both an atherectomy and thrombectomy device, positioning it as 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."
Disease Burden and Clinical Need
PAD 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 and lower limb amputation, highlighting the significant unmet medical need for effective treatment options.
The XTRACT Registry underscores BD's ongoing commitment to innovative technological development and evidence-based research that support physicians and improve patient outcomes in this challenging therapeutic area.
