BD Launches XTRACT Registry to Evaluate Real-World Performance of Rotarex Catheter System in Peripheral Artery Disease
核心洞察
BD (搜索) enrolled the first patient in the XTRACT Registry on September 29, 2025, marking a significant milestone for real-world evidence collection on the Rotarex Catheter System (搜索) in peripheral artery disease (搜索) treatment.
The prospective, multi-center registry study will enroll up to 600 patients across 100 clinical sites in the United States to evaluate safety and effectiveness in everyday clinical practice.
The Rotarex Catheter System (搜索) offers dual functionality as both an atherectomy and thrombectomy device, using three distinct mechanisms to efficiently remove plaque and thrombus from peripheral arteries (搜索).
BD (搜索) (Becton, Dickinson and Company) has achieved a significant milestone in peripheral artery disease (搜索) (PAD (搜索)) research with the enrollment of the first patient in the XTRACT Registry, a comprehensive post-market study designed to evaluate the real-world performance of the Rotarex Catheter System (搜索). The first patient was enrolled on September 29, 2025, under the care of Dr. Kousta Foteh, Chief of Vascular Surgery at Vital Heart & Vein (搜索) medical practice.
Registry Design and Scope
The XTRACT Registry is a prospective, multi-center, single-arm, post-market registry study being conducted in partnership with Co-Principal Investigators Dr. Prakash Krishnan, an interventional cardiologist, and Dr. Todd Berland, a vascular surgeon. The study is expected to enroll up to 600 patients across as many as 100 clinical sites throughout the United States.
Patients enrolled in the registry will undergo comprehensive follow-up evaluations at 30 days, six months, and 12 months post-procedure to assess both safety and effectiveness of the Rotarex Catheter System (搜索) in everyday clinical practice. This longitudinal approach will provide valuable insights into the device's performance across different patient populations and clinical scenarios.
Clinical Impact and First Case Results
Dr. Foteh emphasized the clinical significance of the registry, stating, "This registry will provide critical real-world evidence on the Rotarex Catheter System (搜索) and help physicians refine treatment strategies to improve outcomes for patients with PAD (搜索)." He described the first enrolled case as representative of common clinical presentations, involving an artery that was more than 70% occluded. The versatile Rotarex Catheter successfully removed the debilitating plaque via pedal approach, delivering a favorable result for the patient.
Device Technology and Mechanisms
The Rotarex Catheter System (搜索) is engineered to efficiently remove both plaque and thrombus through three distinct mechanisms of action, making it an effective treatment for various PAD (搜索) lesions in peripheral arteries (搜索). The device offers dual functionality as both an atherectomy and thrombectomy system.
The rotating atraumatic catheter head features blunt facets that modify and detach mixed morphology lesions. Additional luminal gain is achieved through a vortex created around the rotating cylinder. The rotating internal helix generates continuous negative pressure at the tip, actively aspirating and transporting material away from the treatment site.
Disease Burden and Clinical Need
PAD (搜索) represents a significant global health challenge, affecting more than 21 million Americans and over 200 million people worldwide. When left untreated, the condition can lead to increased risk of cardiovascular complications (搜索) and lower limb amputation, highlighting the critical need for effective treatment options.
Strategic Importance
Rob Righi, vice president and general manager of the Vascular Platform at BD (搜索) Interventional–Peripheral Intervention, commented on the milestone: "The enrollment of our first patient marks a significant milestone in our mission to generate robust, real-world evidence supporting the Rotarex Catheter System (搜索). We are excited to begin gathering these additional clinical insights that will help physicians enhance patient outcomes and advance PAD (搜索) care."
The XTRACT Registry reflects BD (搜索)'s continued commitment to advancing evidence-based research and delivering innovative technologies that improve patient outcomes in the peripheral vascular space.