Becton, Dickinson and Company to Initiate Real-World Patient Data Registry for the Rotarex?? Atherectomy System in Treatment of Peripheral Artery Disease

Published: 2025-05-28 08:36:14 ET BDX

Published on 05/28/2025 at 08:36

Becton, Dickinson and Company announced plans to initiate a patient data registry for the Rotarex?? Atherectomy System to measure real-world outcomes for patients with peripheral artery disease (PAD). Known as "XTRACT," this prospective, multi-center, single-arm, post-market registry study will assess the clinical performance of the Rotarex??Arectomy System in the treatment of U.S. patients with PAD lesions.

The XTRACT Registry is being led in partnership with Co-Principal Investigators, Dr. Prakash Krishnan, an interventional cardiologist, and Dr. Todd Berland, a vascular surgeon. The registry will enroll up to 600 patients at approximately 100 clinical sites across the United States, with the first patient enrollment expected later this year. Clinical follow-up evaluations will occur after 30 days, 6 months and 12 months post-procedure to assess safety and effectiveness of outcomes.

The Rotarex?? Athe rectomy 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??

Association is a proven tool for treating PAD. 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 ampututation. The XTRACT Registry underscores BD's ongoing commitment to innovative technological development and evidence-based research that support physicians and improve patient outcomes.