BD to Initiate AG真人官方-World Patient Data Registry for the Rotarex鈩� 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鈩� 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鈩� 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鈩� Atherectomy System nel trattamento della malattia arteriosa periferica (PAD). Il registro arruoler脿 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鈩� 猫 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 Aterectom铆a Rotarex鈩� en el tratamiento de la enfermedad arterial perif茅rica (EAP). El registro incluir谩 hasta 600 pacientes en aproximadamente 100 centros cl铆nicos en Estados Unidos, con seguimientos a los 30 d铆as, 6 meses y 12 meses despu茅s del procedimiento.
El sistema Rotarex鈩� es un dispositivo m铆nimamente invasivo dise帽ado para eliminar tanto la placa como el trombo en las arterias perif茅ricas, funcionando como dispositivo de aterectom铆a y trombectom铆a. El estudio, dirigido por el Dr. Prakash Krishnan y el Dr. Todd Berland, tiene como objetivo evaluar el desempe帽o cl铆nico del sistema en el tratamiento de la EAP, una condici贸n que afecta a m谩s de 21 millones de estadounidenses y a 200 millones de personas en todo el mundo.
BD (NYSE: BDX)電� 毵愳磮霃欕Д歆堩櫂(PAD) 旃橂鞐� 靷毄霅橂姅 Rotarex鈩� Atherectomy System鞚� 鞁れ牅 鞛勳儊 瓴瓣臣毳� 韽夑皜頃橁赴 鞙勴暅 頇橃瀽 雿办澊韯� 霌彪 鞐瓣惮鞚� XTRACT鞚� 鞁滌瀾鞚� 氚滍憸頄堨姷雼堧嫟. 鞚� 霌彪 鞐瓣惮電� 氙戈淡 雮� 鞎� 100臧� 鞛勳儊 旮瓣磤鞐愳劀 斓滊寑 600氇呾潣 頇橃瀽毳� 霌彪頃橂┌, 鞁滌垹 頉� 30鞚�, 6臧滌洈, 12臧滌洈鞐� 頇橃瀽 於旍爜 甏�彀办潉 鞁れ嫓頃╇媹雼�.
Rotarex鈩� 鞁滌姢韰滌潃 毵愳磮 霃欕Д 雮� 頂岆澕韥檧 順堨爠鞚� 鞝滉卑頃橁赴 鞙勴暣 瓿犾晥霅� 斓滌唽 旃姷 鞛レ箻搿�, 鞎勴厡霠夗啝氙胳檧 順堨爠 鞝滉卑 旮半姤鞚� 氇憪 臧栰稊瓿� 鞛堨姷雼堧嫟. 頂勲澕旃挫嫓 韥Μ鞀堧倻 氚曥偓鞕� 韱犽摐 氩岆灉霌� 氚曥偓臧� 欤茧弰頃橂姅 鞚� 鞐瓣惮電� PAD 旃橂鞐愳劀 鞚� 鞁滌姢韰滌潣 鞛勳儊鞝� 靹彪姤鞚� 韽夑皜頃橂姅 瓴冹潉 氇╉憸搿� 頃橂┌, PAD電� 氙戈淡鞐愳劀 2100毵� 氇� 鞚挫儊, 鞝� 靹戈硠鞝侅溂搿� 2鞏� 氇� 鞚挫儊鞚� 頇橃瀽鞐愱矊 鞓來枼鞚� 氙胳箻電� 歆堩櫂鞛呺媹雼�.
BD (NYSE : BDX) a annonc茅 le lancement de XTRACT, un registre de donn茅es patients visant 脿 茅valuer les r茅sultats en conditions r茅elles de son Syst猫me d'Ath茅rectomie Rotarex鈩� dans le traitement de la maladie art茅rielle p茅riph茅rique (MAP). Le registre recrutera jusqu'脿 600 patients dans environ 100 centres cliniques aux 脡tats-Unis, avec des suivis 脿 30 jours, 6 mois et 12 mois apr猫s la proc茅dure.
Le syst猫me Rotarex鈩� est un dispositif peu invasif con莽u pour 茅liminer 脿 la fois la plaque et le thrombus dans les art猫res p茅riph茅riques, servant 脿 la fois d'ath茅rectomie et de thrombectomie. L'茅tude, dirig茅e par le Dr Prakash Krishnan et le Dr Todd Berland, vise 脿 茅valuer la performance clinique du syst猫me dans le traitement de la MAP, une maladie qui touche plus de 21 millions d'Am茅ricains et 200 millions de personnes dans le monde.
BD (NYSE: BDX) hat den Start von XTRACT angek眉ndigt, einem Patientenregister zur Bewertung der realen Behandlungsergebnisse seines Rotarex鈩� Atherectomy Systems bei der Behandlung peripherer arterieller Verschlusskrankheit (PAD). Das Register wird bis zu 600 Patienten an etwa 100 klinischen Standorten in den USA einschlie脽en, mit Nachuntersuchungen nach 30 Tagen, 6 Monaten und 12 Monaten nach dem Eingriff.
Das Rotarex鈩� System ist ein minimalinvasives Ger盲t, das sowohl Plaque als auch Thromben in peripheren Arterien entfernt und somit als Atherektomie- und Thrombektomie-Ger盲t 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 眉ber 21 Millionen Amerikaner und 200 Millionen Menschen weltweit betrifft.
- First comprehensive registry study for Rotarex鈩� 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鈩� 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鈩� 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鈩� 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鈩� 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鈩� 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听Rotarex鈩� 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鈩� 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.听
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 or connect with us on LinkedIn at , X (formerly Twitter) or Instagram .听
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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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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?
