BD to Initiate Real-World Patient Data Registry for the Rotarex™ Atherectomy System in Treatment of Peripheral Artery Disease
BD (NYSE: BDX) has announced the initiation of XTRACT, a patient data registry to evaluate real-world outcomes of its Rotarex™ Atherectomy System in treating peripheral artery disease (PAD). The registry will enroll up to 600 patients across approximately 100 clinical sites in the United States, with patient follow-ups at 30 days, 6 months, and 12 months post-procedure.
The Rotarex™ System is a minimally invasive device designed to remove both plaque and thrombus in peripheral arteries, serving as both an atherectomy and thrombectomy device. The study, led by Dr. Prakash Krishnan and Dr. Todd Berland, aims to assess the system's clinical performance in treating PAD, a condition affecting over 21 million Americans and 200 million people worldwide.
BD (NYSE: BDX) ha annunciato l'avvio di XTRACT, un registro di dati sui pazienti volto a valutare i risultati nella pratica clinica reale del suo Rotarex™ Atherectomy System nel trattamento della malattia arteriosa periferica (PAD). Il registro arruolerà fino a 600 pazienti in circa 100 centri clinici negli Stati Uniti, con follow-up a 30 giorni, 6 mesi e 12 mesi dopo la procedura.
Il sistema Rotarex™ è un dispositivo minimamente invasivo progettato per rimuovere sia la placca che il trombo nelle arterie periferiche, funzionando come dispositivo di aterectomia e trombectomia. Lo studio, guidato dal dott. Prakash Krishnan e dal dott. Todd Berland, mira a valutare le prestazioni cliniche del sistema nel trattamento della PAD, una condizione che colpisce oltre 21 milioni di americani e 200 milioni di persone nel mondo.
BD (NYSE: BDX) ha anunciado el inicio de XTRACT, un registro de datos de pacientes para evaluar los resultados en el mundo real de su Sistema de Aterectomía Rotarex™ en el tratamiento de la enfermedad arterial periférica (EAP). El registro incluirá hasta 600 pacientes en aproximadamente 100 centros clínicos en Estados Unidos, con seguimientos a los 30 días, 6 meses y 12 meses después del procedimiento.
El sistema Rotarex™ es un dispositivo mínimamente invasivo diseñado para eliminar tanto la placa como el trombo en las arterias periféricas, funcionando como dispositivo de aterectomía y trombectomía. El estudio, dirigido por el Dr. Prakash Krishnan y el Dr. Todd Berland, tiene como objetivo evaluar el desempeño clínico del sistema en el tratamiento de la EAP, una condición que afecta a más de 21 millones de estadounidenses y a 200 millones de personas en todo el mundo.
BD (NYSE: BDX)는 말초동맥질환(PAD) 치료에 사용되는 Rotarex™ Atherectomy System의 실제 임상 결과를 평가하기 위한 환자 데이터 등록 연구인 XTRACT의 시작을 발표했습니다. 이 등록 연구는 미국 내 약 100개 임상 기관에서 최대 600명의 환자를 등록하며, 시술 후 30일, 6개월, 12개월에 환자 추적 관찰을 실시합니다.
Rotarex™ 시스템은 말초 동맥 내 플라크와 혈전을 제거하기 위해 고안된 최소 침습 장치로, 아테렉토미와 혈전 제거 기능을 모두 갖추고 있습니다. 프라카시 크리슈난 박사와 토드 벌랜드 박사가 주도하는 이 연구는 PAD 치료에서 이 시스템의 임상적 성능을 평가하는 것을 목표로 하며, PAD는 미국에서 2100만 명 이상, 전 세계적으로 2억 명 이상의 환자에게 영향을 미치는 질환입니다.
BD (NYSE : BDX) a annoncé le lancement de XTRACT, un registre de données patients visant à évaluer les résultats en conditions réelles de son Système d'Athérectomie Rotarex™ dans le traitement de la maladie artérielle périphérique (MAP). Le registre recrutera jusqu'à 600 patients dans environ 100 centres cliniques aux États-Unis, avec des suivis à 30 jours, 6 mois et 12 mois après la procédure.
Le système Rotarex™ est un dispositif peu invasif conçu pour éliminer à la fois la plaque et le thrombus dans les artères périphériques, servant à la fois d'athérectomie et de thrombectomie. L'étude, dirigée par le Dr Prakash Krishnan et le Dr Todd Berland, vise à évaluer la performance clinique du système dans le traitement de la MAP, une maladie qui touche plus de 21 millions d'Américains et 200 millions de personnes dans le monde.
BD (NYSE: BDX) hat den Start von XTRACT angekündigt, einem Patientenregister zur Bewertung der realen Behandlungsergebnisse seines Rotarex™ Atherectomy Systems bei der Behandlung peripherer arterieller Verschlusskrankheit (PAD). Das Register wird bis zu 600 Patienten an etwa 100 klinischen Standorten in den USA einschließen, mit Nachuntersuchungen nach 30 Tagen, 6 Monaten und 12 Monaten nach dem Eingriff.
Das Rotarex™ System ist ein minimalinvasives Gerät, das sowohl Plaque als auch Thromben in peripheren Arterien entfernt und somit als Atherektomie- und Thrombektomie-Gerät dient. Die Studie unter der Leitung von Dr. Prakash Krishnan und Dr. Todd Berland zielt darauf ab, die klinische Leistung des Systems bei der Behandlung von PAD zu bewerten, einer Erkrankung, die über 21 Millionen Amerikaner und 200 Millionen Menschen weltweit betrifft.
- First comprehensive registry study for Rotarex™ System in the US, demonstrating commitment to evidence-based research
- Large-scale study involving 600 patients across 100 clinical sites
- Dual functionality of the device as both atherectomy and thrombectomy tool
- Addresses a significant market with PAD affecting 21M+ Americans
- Results and potential benefits won't be known until study completion in over 12 months
- Significant resource investment required for large-scale registry study
Insights
BD's new registry will generate valuable real-world evidence for their Rotarex system, potentially strengthening their position in the growing PAD market.
BD's announcement of the XTRACT registry represents a strategic move to strengthen the clinical evidence supporting their Rotarex™ Atherectomy System in the US market. This post-market study will enroll 600 patients across approximately 100 clinical sites, providing substantial real-world data on device performance in peripheral artery disease (PAD) treatment.
The registry's design is particularly noteworthy for its comprehensive approach - tracking patients for a full year post-procedure and involving both interventional cardiology and vascular surgery perspectives through dual principal investigators. This multi-specialty collaboration acknowledges the complex treatment landscape for PAD and positions the device for broader adoption across specialties.
What makes this announcement significant is that PAD affects over 21 million Americans and 200 million people worldwide, representing a substantial addressable market. The Rotarex™ system's dual functionality as both an atherectomy and thrombectomy device gives BD a competitive advantage in this space, allowing physicians to address multiple pathologies with a single tool.
This registry aligns with the growing industry emphasis on real-world evidence to supplement traditional clinical trials. For BD, generating this evidence could strengthen reimbursement positioning, support marketing claims, and potentially expand indicated uses. The multi-center approach will help establish the device's effectiveness across diverse patient populations and practice settings, which could accelerate adoption in community hospitals beyond academic centers.
The timing of this registry suggests BD is investing in its peripheral intervention portfolio as part of its broader strategy to grow within the interventional segment amid increasing competition in the PAD treatment space.
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
"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
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.
"The XTRACT Registry is the first comprehensive registry aimed at providing key insights into the real-world applications of the Rotarex™ System," said Rima Alameddine, worldwide president of BD Interventional-Peripheral Intervention. "This study underscores our unwavering commitment to optimizing treatment strategies in partnership with leading physicians to improve patient care."
PAD is a potentially debilitating disease that is estimated to affect more than 21 million Americans and more than 200 million people worldwide and can lead to increased risk of cardiovascular complications and lower limb amputation.1,2 The XTRACT Registry underscores BD's ongoing commitment to innovative technological development and evidence-based research that support physicians and improve patient outcomes.
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 efficiencies, 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, Mary. 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;148:286-296. doi:10.1161/CIR.0000000000001153
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SOURCE BD (Becton, Dickinson and Company)
FAQ
What is the purpose of BD's XTRACT registry for the Rotarex Atherectomy System?
How many patients and clinical sites will be involved in BD's XTRACT registry study?
What is the follow-up timeline for BD's XTRACT registry study?
What makes BD's Rotarex Atherectomy System unique in treating PAD?
How prevalent is peripheral artery disease (PAD) according to BD's announcement?
