BD (Becton, Dickinson and Company) announced on May 28, 2025, plans to initiate a patient data registry for its Rotarex™ Atherectomy System. This registry, named 'XTRACT,' will measure real-world outcomes for patients with peripheral artery disease (PAD) in the United States.
The XTRACT Registry is a prospective, multi-center, single-arm, post-market study designed to assess the clinical performance of the Rotarex™ Atherectomy System in treating PAD lesions. It will enroll up to 600 patients at approximately 100 clinical sites across the U.S., with the first patient enrollment expected later this year.
Clinical follow-up evaluations will occur at 30 days, 6 months, and 12 months post-procedure to assess safety and effectiveness. The Rotarex™ Atherectomy System is a minimally invasive solution designed to efficiently remove both plaque and thrombus in peripheral arteries, addressing a debilitating disease affecting over 21 million Americans.
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