BD Launches US Patient Study to Track Real-World Results of Its PAD Treatment Device

BD (Becton, Dickinson and Company) (NYSE:BDX), a leading global medical technology company, today 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™ Atherectomy 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.

"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."

The Rotarex™ Atherectomy 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™ Atherectomy System is a proven tool for treating PAD.