October 10, 2025- BD announced the enrollment of the first patient in the XTRACT™ Registry, a prospective, multi-center, single-arm, post-market registry study designed to evaluate the real-world performance of the Rotarex™ Catheter System in the treatment of patients with peripheral artery disease (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 first patient was enrolled on September 29, 2025, under the care of Dr. Kousta Foteh, Chief of Vascular Surgery at Vital Heart & Vein medical practice. With patient participation, the XTRACT™ Registry will now collect valuable data to inform clinical decision-making and optimize treatment strategies for PAD.
The XTRACT™ Registry is expected to enroll up to six hundred patients in as many as one hundred clinical sites in the United States. Patients will undergo follow-up evaluations at 30 days, six months, and 12 months post-procedure to assess both safety and effectiveness of the Rotarex™ Catheter System in everyday clinical practice.