BD Rotarex to Be Assessed in XTRACT Postmarket Registry

May 28, 2025—BD (Becton, Dickinson and Company) announced plans to initiate the XTRACT patient data registry for its Rotarex atherectomy system. The registry will measure real-world outcomes with the device in the treatment of patients with peripheral artery disease (PAD) in the United States.

According to the company, the prospective, multicenter, single-arm XTRACT postmarket registry will assess the clinical performance of Rotarex in treating PAD lesions. The registry will enroll up to 600 patients at approximately 100 clinical sites across the United States. The first patient enrollment is expected to occur later this year.

Clinical follow-up evaluations will occur at 30 days, 6 months, and 12 months postprocedure to assess the Rotarex system’s safety and effectiveness, advised BD.

The XTRACT registry is being led by Coprincipal Investigators Prakash Krishnan, MD, an interventional cardiologist, and Todd Berland, MD, a vascular surgeon.

“This registry will provide valuable data to support clinical decision-making and enhance patient outcomes in the management of PAD,” commented Dr. Krishnan in BD’s press release. “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 United States patient population.”

The minimally invasive Rotarex atherectomy system is designed to remove plaque and thrombus in peripheral arteries and is indicated as an atherectomy and thrombectomy device, noted the company.