AngioDynamics Initiates AMBITION BTK RCT and Registry to Advance Treatment for Critical Limb Ischemia
AngioDynamics (NASDAQ: ANGO) has launched the AMBITION BTK study, a multicenter randomized controlled trial evaluating their Auryon Atherectomy System in treating critical limb ischemia. The trial will compare the system combined with standard balloon angioplasty versus angioplasty alone for infrapopliteal lesions.
The study will enroll up to 200 subjects across 30 hospital-based sites, with an additional registry tracking up to 1,500 subjects. The Auryon laser system, which has already treated over 100,000 patients worldwide, can treat various infrainguinal lesion types including above-the-knee, below-the-knee, and in-stent restenosis.
This initiative builds on previous successful trials where the system effectively treated 61 complex calcified lesions in 60 patients across four U.S. centers. The technology uses a 355nm wavelength laser platform that enables targeted treatment of peripheral artery disease while minimizing perforation risks.
AngioDynamics (NASDAQ: ANGO) ha lanciato lo studio AMBITION BTK, uno studio controllato randomizzato multicentrico che valuta il proprio Auryon Atherectomy System nel trattamento dell'ischemia critica degli arti. Lo studio confronterà il sistema combinato con l'angioplastica con pallone standard rispetto all'angioplastica da sola per le lesioni infrapopliteali.
Lo studio arruolerà fino a 200 soggetti in 30 centri ospedalieri, con un registro aggiuntivo che monitorerà fino a 1.500 soggetti. Il sistema laser Auryon, che ha già trattato oltre 100.000 pazienti in tutto il mondo, può trattare vari tipi di lesioni infrainguinali, comprese quelle sopra e sotto il ginocchio, oltre alla restenosi in-stent.
Questa iniziativa si basa su precedenti trial di successo in cui il sistema ha trattato efficacemente 61 lesioni calcificate complesse in 60 pazienti in quattro centri negli Stati Uniti. La tecnologia utilizza una piattaforma laser a lunghezza d'onda di 355 nm che consente un trattamento mirato della malattia arteriosa periferica, riducendo al contempo i rischi di perforazione.
AngioDynamics (NASDAQ: ANGO) ha lanzado el estudio AMBITION BTK, un ensayo controlado aleatorio multicéntrico que evalúa su Auryon Atherectomy System en el tratamiento de la isquemia crítica de las extremidades. El ensayo comparará el sistema combinado con la angioplastia con globo estándar frente a la angioplastia sola para lesiones infrapopliteales.
El estudio inscribirá hasta 200 sujetos en 30 sitios hospitalarios, con un registro adicional que rastreará hasta 1,500 sujetos. El sistema láser Auryon, que ya ha tratado a más de 100,000 pacientes en todo el mundo, puede tratar varios tipos de lesiones infrainguinales, incluidas las que están por encima y por debajo de la rodilla, así como la restenosis in-stent.
Esta iniciativa se basa en ensayos anteriores exitosos donde el sistema trató efectivamente 61 lesiones calcificadas complejas en 60 pacientes en cuatro centros de EE. UU. La tecnología utiliza una plataforma láser con longitud de onda de 355 nm que permite un tratamiento dirigido de la enfermedad arterial periférica, minimizando al mismo tiempo los riesgos de perforación.
AngioDynamics (NASDAQ: ANGO)는 급성 말초동맥 질환 치료를 위한 Auryon Atherectomy System의 유효성을 평가하는 다기관 무작위 대조 연구인 AMBITION BTK 연구를 시작했습니다. 이 연구는 표준 풍선 성형술과 결합된 시스템과 풍선 성형술 단독을 비교할 것입니다.
이 연구는 최대 30개 병원에서 200명을 등록하고, 추가로 1,500명까지 추적하는 등록부를 유지할 예정입니다. Auryon 레이저 시스템은 전 세계에서 10만 명 이상의 환자를 치료한 경험이 있으며, 무릎 위, 무릎 아래 및 스텐트 재협착을 포함한 다양한 하부 동맥 병변을 치료할 수 있습니다.
이 이니셔티브는 미국 내 네 곳의 중심에서 60명의 환자에서 61개의 복잡한 석회화 병변을 효과적으로 치료한 성공적인 이전 연구를 기반으로 합니다. 이 기술은 355nm 파장 레이저 플랫폼을 사용하여 말초 동맥 질환의 표적 치료를 가능하게 하며, 천공 위험을 최소화합니다.
AngioDynamics (NASDAQ: ANGO) a lancé l'étude AMBITION BTK, un essai contrôlé randomisé multicentrique évaluant leur Auryon Atherectomy System dans le traitement de l'ischémie critique des membres. L'essai comparera le système associé à l'angioplastie par ballonnet standard par rapport à l'angioplastie seule pour les lésions infrapopliteales.
L'étude inscrira jusqu'à 200 sujets dans 30 sites hospitaliers, avec un registre supplémentaire suivant jusqu'à 1 500 sujets. Le système laser Auryon, qui a déjà traité plus de 100 000 patients dans le monde, peut traiter divers types de lésions infrainguinales, y compris au-dessus et en dessous du genou, ainsi que la resténose intra-stent.
Cette initiative s'appuie sur des essais précédents réussis où le système a efficacement traité 61 lésions calcifiées complexes chez 60 patients dans quatre centres aux États-Unis. La technologie utilise une plateforme laser à longueur d'onde de 355 nm qui permet un traitement ciblé de la maladie artérielle périphérique tout en minimisant les risques de perforation.
AngioDynamics (NASDAQ: ANGO) hat die AMBITION BTK-Studie gestartet, eine multizentrische, randomisierte kontrollierte Studie zur Bewertung ihres Auryon Atheriektomiesystems zur Behandlung von kritischer Gliedmaßenischämie. Die Studie wird das System, das mit der Standardballonangioplastie kombiniert ist, mit der alleinigen Angioplastie für infrapopliteale Läsionen vergleichen.
In der Studie sollen bis zu 200 Probanden an 30 Krankenhäusern eingeschlossen werden, zusätzlich wird ein Register eingerichtet, das bis zu 1.500 Probanden verfolgt. Das Auryon-Lasersystem, das bereits über 100.000 Patienten weltweit behandelt hat, kann verschiedene Arten von infrainguinalen Läsionen behandeln, einschließlich über dem Knie, unter dem Knie und in-stent Restenosen.
Diese Initiative baut auf früheren erfolgreichen Studien auf, bei denen das System erfolgreich 61 komplexe verkalkte Läsionen bei 60 Patienten in vier US-Zentren behandelt hat. Die Technologie nutzt eine Laserplattform mit einer Wellenlänge von 355 nm, die eine zielgerichtete Behandlung der peripheren Arterienerkrankung ermöglicht und gleichzeitig das Risiko von Perforationen minimiert.
- Auryon Atherectomy System has already treated over 100,000 patients globally
- Previous trial successfully treated 61 complex lesions in 60 patients with strong clinical outcomes
- System demonstrates versatility in treating multiple lesion types (ATK, BTK, ISR)
- None.
Insights
The initiation of the AMBITION BTK trial represents a pivotal milestone for AngioDynamics' commercial strategy in the $2.5 billion peripheral vascular market. The dual-approach study design - combining a rigorous RCT with a large-scale registry - is particularly shrewd, as it will generate both high-quality efficacy data and real-world evidence, which are important for securing favorable reimbursement decisions and driving physician adoption.
The trial's focus on below-the-knee lesions is strategically significant, targeting an underserved market segment where treatment options remain With over 230 million adults affected by PAD worldwide and the increasing prevalence of diabetes driving BTK disease cases, this represents a substantial market opportunity. The Auryon system's unique 355nm wavelength laser technology offers distinct advantages over traditional treatments, particularly in treating calcified lesions without thermal damage.
The involvement of prominent physicians from institutions like Massachusetts General Hospital and Harvard Medical School adds significant credibility to the trial. The system's track record of treating over 100,000 patients demonstrates established market penetration, while the new trial could expand its addressable market and strengthen its competitive position against alternative treatments like drug-coated balloons and traditional atherectomy devices.
Trial Evaluates Effectiveness of Innovative Auryon Atherectomy System in Complex Below-the-Knee Cases
AMBITION BTK is a multicenter, randomized controlled trial (RCT) designed to evaluate the clinical outcomes of the Auryon Atherectomy System in combination with standard balloon angioplasty compared to standard balloon angioplasty alone for the treatment of infrapopliteal lesions in patients with critical limb ischemia. The trial will enroll up to 200 subjects across up to 30 hospital-based sites. Additionally, up to 1,500 subjects treated with the Auryon Atherectomy System at the same sites who do not meet the eligibility criteria of the RCT will be enrolled in a companion Registry.
Lower extremity peripheral artery disease (PAD) affects more than 230 million adults worldwide and is associated with an increased risk of various adverse clinical outcomes.1 In its most severe form, critical limb ischemia patients are often treated with lower extremity amputation (LEA).2
“We are dedicated to expanding innovative treatment options for peripheral artery disease, particularly in challenging cases like below-the-knee lesions,” said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs. “The AMBITION BTK RCT and Registry represents an important advancement in evaluating the clinical benefits of the Auryon Atherectomy System. Physicians have expressed strong interest in the platform's unique capabilities, and we are eager to demonstrate further its potential to improve outcomes for patients with critical limb ischemia.”
The Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee (ATK), below-the-knee (BTK) and In-Stent Restenosis (ISR)3,4,5,6 and to date, it has been used to treat more than 100,000 patients7 in
“With the global rise in diabetes, we are seeing a growing number of patients with severe tibial disease,” said AMBITION BTK Co-Principal Investigator Anahita Dua, MD, MS, MBA, FACS, vascular surgeon at Massachusetts General Hospital and an associate professor of Surgery at Harvard Medical School. “In the United States, treatment options for below-the-knee lesions remain limited, often relying primarily on POBA (Percutaneous Old Balloon Angioplasty). These patients frequently present with tibial disease that can extend throughout the entire vessel. An innovative tool like the Auryon laser, which can restore laminar flow, could be a game-changer in their care.”
AMBITION BTK builds upon the positive outcomes of a prior multicenter, prospective trial that evaluated the safety and effectiveness of the Auryon laser atherectomy system in treating BTK lesions in patients with limb ischemia. The earlier study successfully treated 61 complex, calcified lesions across four
“The AMBITION BTK RCT and Registry represents an important advance in the evidence supporting the benefits of laser atherectomy in achieving acute and long-term procedural success,” said AMBITION BTK Co-Principal Investigator Ehrin Armstrong, FACC, FSCAI, FSVM, MD, MSc, Interventional Cardiologist and Vascular Disease, Director of Clinical Research, Advanced Heart and Vein Center. “The trial will address an important unmet need for patients with critical limb ischemia and tibial artery disease. The data for the trial will also help better understand the Auryon laser's unique mechanism of action in complex and calcified lesions.”
The technology underlying the Auryon Atherectomy System has been shown in clinical studies to be effective in treating lesions ranging from soft plaque to severely calcified.3,4,5 The System uses a 355nm wavelength laser platform, enabling the use of short UV laser pulses with targeted biological reactions that are effective in treating PAD while minimizing the risk of perforation and preserving the ability to vaporize lesions without thermal ablation.3,5,6,9,10
On February 1, the Company will host its inaugural Cardiovascular Scientific Forum (CVSF). The event will bring together leading physicians and thought leaders in the cardiovascular field to present groundbreaking research, discuss emerging clinical trends, and showcase advancements shaping the future of patient care, including the AMBITION BTK RCT and Registry.
Visit https://clinicaltrials.gov/study/NCT06777901 for more information about the AMBITION BTK RCT and Registry.
For important risk information, visit www.angiodynamics.com/about-us/risk-information/.
About the Auryon Atherectomy System
The Auryon Atherectomy System uses innovative technology to deliver powerful treatment of arterial occlusions. The Auryon Atherectomy System is the first laser atherectomy system to efficiently treat any lesion type, any lesion length, at any lesion location, with minimal impact on vessel walls.3,5,9,10 The Auryon Atherectomy System uses solid-state laser technology for the treatment of PAD and is FDA cleared with an indication for treatment, including atherectomy, of infrainguinal stenoses and occlusions, including ISR.4,6 The Auryon System’s targeted biological reactions minimize the risk of perforation and preserve the ability to vaporize lesions without thermal ablation.3,5,9,10 The Auryon System uses a 355nm wavelength laser platform which enables the use of longer wavelengths and shorter pulses to produce a groundbreaking delivery of short UV laser pulses.4 For more information, please visit www.Auryon-PAD.com.
About AngioDynamics, Inc.
AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life.
The Company’s innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit www.angiodynamics.com.
Safe Harbor
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics’ expectations, expressed or implied. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement of AngioDynamics’ technology or assertions that AngioDynamics’ technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign healthcare reforms and government regulations, results of pending or future clinical trials, overall economic conditions (including inflation, labor shortages and supply chain challenges including the cost and availability of raw materials), the results of on-going litigation, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to obtain regulatory clearances or approval of its products, or to integrate acquired businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2024. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
AngioDynamics, the AngioDynamics logo and Auryon are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are property of their respective owners.
1 https://www.ahajournals.org/doi/10.1161/CIR.0000000000001005
2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4107174/#:~:text=In%20its%20most%20severe%20form,the%20performing%20of%20major%20LEA
3 Rundback J, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-LaserTM IDE study. Catheter Cardiovasc Interv. 2019;1-8.
4 Auryon System Indications for Use
5 Shammas NW, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Acute and 30-day safety and effectiveness evaluation of Eximo Medical’s B-LaserTM, a novel atherectomy device, in subjects affected with infrainguinal peripheral arterial disease: Results of the EXPAD-03 trial. Cardiovas Revasc Med. 2020;21(1):86-92
6 Built-in aspiration available only with the 2.0- and 2.35-mm catheters.
7 AngioDynamics’ J.P. Morgan Healthcare Conference Presentation https://investors.angiodynamics.com/static-files/f7e7b49f-744d-4169-9a66-95a78d2f1525. Published 2025.
8 ClinicalTrials.gov. (2023). Evaluation of the safety and efficacy of the Auryon Atherectomy System for the treatment of below-the-knee arteries in patients with chronic limb-threatening ischemia (NCT05284240).
9 Herzog A, Bogdan S, Glikson M, Ishaaya AA, Love C. Selective tissue ablation using laser radiation at 355 nm in lead extraction by a hybrid catheter; a preliminary report. Lasers Surg Med. 2016;48(3):281-287
10 Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644
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518-795-1408
strowbridge@angiodynamics.com
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Source: AngioDynamics, Inc.
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