BD Reaches Major Milestone for Rotarex™ Catheter System with First Patient Enrolled in XTRACT™ Registry to Advance Real-World Evidence in Peripheral Artery Disease
BD (NYSE: BDX) announced enrollment of the first patient in the XTRACT™ Registry on September 29, 2025, a prospective, multi-center, single-arm post-market study to evaluate real-world performance of the Rotarex™ Catheter System for peripheral artery disease (PAD).
The registry plans up to 600 patients across as many as 100 U.S. sites with follow-ups at 30 days, 6 months, and 12 months to assess safety and effectiveness. The Rotarex catheter offers combined atherectomy and thrombectomy mechanisms to remove plaque and thrombus. BD said the registry will generate real-world evidence to inform clinical decision-making and treatment strategies for PAD.
BD (NYSE: BDX) ha annunciato l'iscrizione del primo paziente nel Registro XTRACT™ il 29 settembre 2025, uno studio prospettico, multicentrico, a braccio unico post-commercializzazione per valutare la performance nel mondo reale del sistema di cateteri Rotarex™ per la malattia delle arterie periferiche (PAD).
Il registro prevede fino a 600 pazienti in fino a 100 sedi negli Stati Uniti con follow-up a 30 giorni, 6 mesi e 12 mesi per valutare sicurezza ed efficacia. Il catetere Rotarex offre meccanismi combinati di atherectomy e thrombectomy per rimuovere placca e trombo. BD ha dichiarato che il registro genererà evidenze real-world per supportare la decisione clinica e le strategie di trattamento per PAD.
BD (NYSE: BDX) anunció la inscripción del primer paciente en el Registro XTRACT™ el 29 de septiembre de 2025, un estudio prospectivo, multicéntrico, un solo brazo, posterior al mercado para evaluar el desempeño en la vida real del sistema de catéter Rotarex™ para la enfermedad de las arterias periféricas (PAD).
El registro planea hasta 600 pacientes en hasta 100 sitios en EE. UU. con seguimientos a 30 días, 6 meses y 12 meses para evaluar seguridad y eficacia. El catéter Rotarex ofrece mecanismos combinados de aterectomía y trombectomía para eliminar placa y trombo. BD dijo que el registro generará evidencia del mundo real para orientar la toma de decisiones clínicas y las estrategias de tratamiento para PAD.
BD (NYSE: BDX)는 XTRACT™ 레지스트리의 첫 번째 환자 등록을 2025년 9월 29일에 발표했으며, 이는 말초동맥질환(PAD)에 대한 Rotarex™ 카테터 시스템의 실세계 성능을 평가하기 위한 전향적, 다기관, 단일군 포스트마켓 연구이다.
레지스트리는 미국 내 최대 100개 사이트에서 최대 600명의 환자를 대상으로 30일, 6개월, 12개월의 추적 조사를 통해 안전성과 유효성을 평가할 계획이다. Rotarex 카테타는 플라크와 혈전 제거를 위해 혈관성 경계절차를 결합한 혈전절제 및 혈전제거 메커니즘을 제공한다. BD는 레지스트리가 PAD에 대한 임상 의사결정 및 치료 전략을 알리기 위한 실세계 증거를 생성할 것이라고 밝혔다.
BD (NYSE: BDX) a déclaré l'enregistrement du premier patient dans le registre XTRACT™ le 29 septembre 2025, une étude prospective, multicentrique, en bras unique post-commercialisation pour évaluer la performance dans la vie réelle du système de cathéter Rotarex™ pour la maladie artérielle périphérique (PAD).
Le registre prévoit jusqu'à 600 patients dans jusqu'à 100 sites aux États-Unis avec des suivis à 30 jours, 6 mois et 12 mois pour évaluer la sécurité et l'efficacité. Le cathéter Rotarex offre des mécanismes combinés d'athérectomie et de thrombectomie pour éliminer la plaque et les thrombus. BD a déclaré que le registre générera des preuves du monde réel pour éclairer la prise de décision clinique et les stratégies de traitement pour PAD.
BD (NYSE: BDX) gab die Aufnahme des ersten Patienten in das XTRACT™-Register am 29. September 2025 bekannt, eine prospektive, multizentrische, eindimensionale Nach-Marketing-Studie zur Bewertung der Real-World-Leistung des Rotarex™-Kathetersystems bei peripherer arterieller Erkrankung (PAD).
Das Register plant bis zu 600 Patienten in bis zu 100 Standorten in den USA mit Nachuntersuchungen zu 30 Tagen, 6 Monaten und 12 Monaten, um Sicherheit und Wirksamkeit zu beurteilen. Der Rotarex-Katheter bietet kombinierte Atherektomie- und Thrombektomie-Mechanismen, um Plaque und Thrombus zu entfernen. BD sagte, das Register werde real-world-Evidence liefern, um klinische Entscheidungen und Behandlungsstrategien für PAD zu unterstützen.
BD (NYSE: BDX) أعلـن عن تسجيل أول مريض في سجل XTRACT™ في 29 سبتمبر 2025، وهو دراسة استشرافية متعددة المراكز بجهة واحده ما بعد التسويق لتقييم الأداء في العالم الحقيقي لنظام قثطرة Rotarex™ لعلاج أمراض الشرايين الطرفية (PAD).
يخطط السجل لغاية 600 مريض عبر حتى 100 موقع في الولايات المتحدة مع متابعة عند 30 يوماً و6 أشهر و12 شهراً لتقييم السلامة والفعالية. يوفر قثطرة Rotarex آليات مدمجة لجراحة الاستئصال والتخثر لإزالة اللويحات والخثر. قالت BD إن السجل سيولد أدلة واقعية لدعم اتخاذ القرار السريري واستراتيجيات العلاج لـ PAD.
BD (NYSE: BDX) 已宣布在 2025年9月29日登记XTRACT™注册表中的第一名患者，这是一个前瞻性、多中心、单臂、市场后研究，评估 Rotarex™导管系统在周围动脉疾病（PAD）中的现实世界表现。
该注册表计划在多达 100个美国站点覆盖多达 600名患者，并在 30天、6个月和12个月进行随访，以评估安全性和有效性。Rotarex导管提供合并的动脉粥样斑块切除和血栓切除机制，以清除斑块和血栓。BD表示，该注册表将产生现实世界证据，为PAD的临床决策和治疗策略提供信息。
- First patient enrolled on Sept 29, 2025
- Planned enrollment of up to 600 patients
- Up to 100 U.S. clinical sites expected
- Systematic follow-up at 30 days, 6 months, 12 months
- Device has dual atherectomy and thrombectomy functionality
- Single-arm registry limits comparative effectiveness conclusions
Insights
BD enrolled the first patient into the XTRACT™ Registry to collect real‑world data on the Rotarex™ Catheter System.
BD's enrollment of the first patient on
Key dependencies include site activation pace, patient follow‑up completeness at 30 days, six months, and 12 months, and consistent outcome definitions across centers. Registry data quality will hinge on procedural standardization and adjudication of events; early enrollment by experienced operators reduces procedural variability but does not substitute for controlled comparative evidence.
Watch for enrollment milestones and core endpoint reports at the 12‑month follow‑up horizon, plus interim safety signals at 30 days. These registry results should inform clinical practice patterns and reimbursement discussions if they demonstrate consistent, generalizable safety and effectiveness across the planned multisite cohort.
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.
"We are proud to be the first site to enroll a patient in the XTRACT™ Registry," said Dr. Foteh. "This registry will provide critical real-world evidence on the Rotarex™ Catheter System and help physicians refine treatment strategies to improve outcomes for patients with PAD. This first case is similar to what we commonly see in our clinic, where an artery is more than
The XTRACT™ Registry is expected to enroll up to six hundred patients in as many as one hundred clinical sites in
"The enrollment of our first patient marks a significant milestone in our mission to generate robust, real-world evidence supporting the Rotarex™ Catheter System," said Rob Righi, vice president and general manager of the Vascular Platform at BD Interventional–Peripheral Intervention. "We are excited to begin gathering these additional clinical insights that will help physicians enhance patient outcomes and advance PAD care, and we look forward to building on this landmark initial enrollment."
The Rotarex™ Catheter System is designed to efficiently remove both plaque and thrombus by using three distinct mechanisms of action, making it an effective treatment for various PAD lesions in peripheral arteries. Offering dual functionality as both an atherectomy and thrombectomy device, the rotating atraumatic catheter head with blunt facets modifies and detaches mixed morphology lesions. Additional luminal gain is achieved by a vortex created around the rotating cylinder. The rotating internal helix creates continuous negative pressure at the tip, actively aspirating and transporting material away.
PAD affects more than 21 million Americans1 and over 200 million people worldwide.2 Left untreated, it can lead to increased risk of cardiovascular complications and lower limb amputation.1,2 The XTRACT™ Registry reflects the continued commitment of BD to advancing evidence-based research and delivering innovative technologies that improve outcomes for patients.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiency, improve safety, and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson.
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1 Yost M. The current
2 Allison MA, Armstrong DG, Goodney PP, et al. Health disparities in peripheral artery disease: A scientific statement from the American Heart Association. Circulation. 2023;148(3):286-296. doi:10.1161/CIR.0000000000001153.
BD, the BD Logo, Rotarex, and XTRACT are trademarks of Becton, Dickinson and Company or its affiliates. © 2025 BD. All Rights Reserved. BD-162804
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