AngioDynamics Announces CE Mark Approval in Europe for the Auryon System
AngioDynamics (NASDAQ: ANGO) has received European CE Mark approval for its Auryon Atherectomy System, a revolutionary solid-state laser technology for treating Peripheral Artery Disease (PAD). This approval enables the company to enter the European market, expanding its reach in the global PAD market valued at $1.1 billion.
The Auryon System, which received FDA clearance in 2020, has already treated over 50,000 patients in the US. Clinical studies have shown its effectiveness in treating various lesion types with minimal vessel wall impact. The system uses a 355nm wavelength laser platform, allowing for targeted biological reactions without thermal ablation.
Recent studies, including the PATHFINDER registry, have demonstrated the system's safety and efficacy in treating complex PAD cases, showing significant improvements in patient outcomes.
AngioDynamics (NASDAQ: ANGO) ha ricevuto l'
Il Sistema Auryon, che ha ricevuto l'autorizzazione dalla FDA nel 2020, ha già trattato oltre 50.000 pazienti negli Stati Uniti. Studi clinici hanno dimostrato la sua efficacia nel trattamento di vari tipi di lesioni con un impatto minimale sulla parete vascolare. Il sistema utilizza una Piattaforma laser a lunghezza d'onda di 355 nm, che consente reazioni biologiche mirate senza ablazione termica.
Studi recenti, incluso il registro PATHFINDER, hanno dimostrato la sicurezza e l'efficacia del sistema nel trattamento di casi complessi di PAD, mostrando miglioramenti significativi negli esiti per i pazienti.
AngioDynamics (NASDAQ: ANGO) ha recibido la aprobación del marcado CE europeo para su Sistema de Aterectomía Auryon, una tecnología láser de estado sólido revolucionaria para el tratamiento de la Enfermedad Arterial Periférica (PAD). Esta aprobación permite a la compañía ingresar al mercado europeo, expandiendo su alcance en el mercado global de PAD valorado en 1.1 mil millones de dólares.
El Sistema Auryon, que recibió la autorización de la FDA en 2020, ya ha tratado a más de 50,000 pacientes en EE. UU.. Los estudios clínicos han demostrado su efectividad en el tratamiento de varios tipos de lesiones con un impacto mínimo en la pared del vaso. El sistema utiliza una plataforma láser de longitud de onda de 355 nm, permitiendo reacciones biológicas específicas sin ablación térmica.
Estudios recientes, incluido el registro PATHFINDER, han demostrado la seguridad y eficacia del sistema en el tratamiento de casos complejos de PAD, mostrando mejoras significativas en los resultados de los pacientes.
AngioDynamics (NASDAQ: ANGO)는 유럽 CE 마크 승인을 받아 Auryon 혈전절제기 시스템을 출시하였습니다. 이는 말초동맥질환(PAD) 치료를 위한 혁신적인 고체 레이저 기술입니다. 이 승인은 회사가 유럽 시장에 진입할 수 있게 하여, 110억 달러 규모의 글로벌 PAD 시장에서의 영향력을 확장합니다.
Auryon 시스템은 2020년 FDA 승인을 받았으며, 이미 미국에서 50,000명 이상의 환자를 치료했습니다. 임상 연구에서 다양한 병변 유형을 최소한의 혈관벽 영향을 주면서 치료하는 데 효과적임을 입증했습니다. 이 시스템은 355nm 파장 레이저 플랫폼을 사용하여 열을 가하지 않고도 타깃 생물학적 반응을 유도합니다.
최근 연구, 특히 PATHFINDER 등록부에서 이 시스템의 안전성과 복잡한 PAD 사례 치료의 효능을 입증하며 환자 결과에 있어서 상당한 개선을 보여주었습니다.
AngioDynamics (NASDAQ: ANGO) a reçu l'
Le Système Auryon, qui a reçu l'autorisation de la FDA en 2020, a déjà traité plus de 50 000 patients aux États-Unis. Des études cliniques ont montré son efficacité dans le traitement de divers types de lésions avec un impact minimal sur la paroi des vaisseaux. Le système utilise une plateforme laser de longueur d'onde de 355 nm, permettant des réactions biologiques ciblées sans ablation thermique.
Des études récentes, y compris le registre PATHFINDER, ont démontré la sécurité et l'efficacité du système dans le traitement de cas complexes de PAD, montrant des améliorations significatives des résultats pour les patients.
AngioDynamics (NASDAQ: ANGO) hat die europäische CE-Kennzeichnung für sein Auryon-Atherektomiesystem erhalten, eine revolutionäre Laser-Technologie mit Festkörpertechnik zur Behandlung der peripheren Arterienerkrankung (PAD). Diese Genehmigung ermöglicht es dem Unternehmen, in den europäischen Markt einzutreten und seine Reichweite im globalen PAD-Markt im Wert von 1,1 Milliarden Dollar auszudehnen.
Das Auryon-System, das 2020 von der FDA zugelassen wurde, hat bereits über 50.000 Patienten in den USA behandelt. Klinische Studien haben seine Wirksamkeit bei der Behandlung verschiedener Läsionstypen mit minimalem Einfluss auf die Gefäßwand gezeigt. Das System verwendet eine Laserplattform mit einer Wellenlänge von 355 nm, die gezielte biologische Reaktionen ohne thermische Ablation ermöglicht.
Neuere Studien, einschließlich des PATHFINDER-Registers, haben die Sicherheit und Wirksamkeit des Systems bei der Behandlung komplexer PAD-Fälle nachgewiesen und signifikante Verbesserungen bei den Patientenergebnissen gezeigt.
- Received CE Mark approval for Auryon Atherectomy System, enabling entry into the European market
- Expands company's reach in the global PAD market valued at $1.1 billion
- Auryon System has already treated over 50,000 patients in the US since FDA clearance in 2020
- Clinical studies show effectiveness in treating various lesion types with minimal vessel wall impact
- PATHFINDER registry demonstrates significant improvements in patient outcomes
- None.
Insights
The CE Mark approval for AngioDynamics' Auryon Atherectomy System is a significant development in the PAD treatment landscape. This innovative solid-state laser technology offers versatile treatment options for various lesion types, potentially improving outcomes for patients with complex PAD cases.
The system's ability to treat lesions of any type, length, or location with minimal vessel wall impact could lead to reduced complications and improved patient recovery. The expansion into the European market, valued at
However, investors should note that market penetration and adoption rates in Europe may differ from the U.S. experience. The company will need to navigate different healthcare systems and demonstrate cost-effectiveness to achieve widespread adoption.
The CE Mark approval opens up a new revenue stream for AngioDynamics in the European market. With over 50,000 patients treated in the U.S. since 2020, the Auryon System has demonstrated market traction. The expansion into Europe's
Investors should monitor the pace of European market penetration and any impact on the company's gross margins. Initial costs associated with market entry and potential pricing pressures in different European healthcare systems may affect short-term profitability. However, if adoption rates mirror U.S. success, this could be a strong growth driver for AngioDynamics in the medium to long term.
The Auryon Atherectomy System's CE Mark approval is a welcome addition to the European PAD treatment arsenal. Its ability to treat diverse lesion types, including challenging cases like In-Stent Restenosis and Critical Limb Ischemia, addresses a significant clinical need.
The system's 355nm wavelength laser platform offers precise treatment with minimal thermal damage, potentially reducing complications. The PATHFINDER registry results, showing no flow-limiting dissections and improvements in clinical outcomes, are particularly encouraging.
However, long-term data on durability of results and cost-effectiveness compared to existing treatments will be important for widespread adoption. European clinicians will likely closely monitor real-world performance as the system rolls out across different healthcare settings.
Regulatory approval enables entry of Auryon Atherectomy System in European market
The Auryon Atherectomy System uses revolutionary solid-state laser technology to treat PAD lesions and occlusions effectively. Auryon is the first laser atherectomy system to efficiently treat lesions of any type, length, or location (above and below the knee)1,2,3, with minimal impact on vessel walls.
“The CE Mark approval of the Auryon System is a significant milestone that underscores our commitment to bringing safe and effective solutions to healthcare professionals treating peripheral artery disease,” said Laura Piccinini, AngioDynamics Senior Vice President and General Manager of Endovascular Therapies and International. “This approval validates the clinical value of the Auryon System and allows us to expand our presence in
The Auryon Atherectomy System, which received FDA 510(k) clearance in 2020, has treated over 50,000 patients in
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 calcified1,2,3. 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 ablation1,3,8,9.
The Auryon Atherectomy System features aspiration and off-set capability in certain catheter sizes, allowing clinicians to address the risk of embolization and to treat all lesion types1, while answering a need for non-surgical intervention options for PAD, including ISR, and CLI.
Nicolas Shammas, MD, and the Midwest Cardiovascular Research Foundation have published a prospective, multi-center, single-arm investigation examining the use of the Auryon laser system in patients with below-the-knee critical limb ischemia (CLI). The study demonstrated that the Auryon laser system effectively reduced residual stenosis to ≤
The recently published PATHFINDER registry further supports these findings, showing no flow-limiting dissections and significant improvement in Ankle-Brachial Index (ABI), Rutherford classification, and Walking Impairment Questionnaires at both 6 and 12 months in a real-world clinical setting7.
These results add to a growing body of evidence indicating that the Auryon laser system is a safe and effective treatment option for a wide range of complex patients with PAD.
For important risk information, visit www.auryon-system.com/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 walls1,3,8,9. The Auryon Atherectomy System uses solid-state laser technology for the treatment of PAD and is CE Marked with an indication for treatment, including atherectomy, of infrainguinal stenoses and occlusions, including ISR10,11. The Auryon System’s targeted biological reactions minimize the risk of perforation and preserve the ability to vaporize lesions without thermal ablation1,3,8,9. 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 pulses8. 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.
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.
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.
1 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-Laser IDE study. Catheter Cardiovasc Interv. 2019;1-8.
2 Auryon System Indications for Use
3 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-Laser , 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
4 Horváth, L., Németh, N., Fehér, G., Kívés, Z., Endrei, D., & Boncz, I. (2023). Epidemiology of peripheral artery disease: Narrative review. Life, 13(6), 1257. https://pubmed.ncbi.nlm.nih.gov/35888129/
5 AngioDynamics’ Canaccord Genuity 44th Annual Growth Conference https://investors.angiodynamics.com/static-files/922d9caa-1088-4e4a-ba23-2f1486aa8817. Published 2024.
6 Shammas NW, Yates T, Sastry A, Ricotta J, Beasley R, Swee W, Torey JT, Shammas GA, Jones-Miller S, Corbet M. Prospective, Multi-center, Single-Arm Study of the Auryon Laser System for Treatment of Below-the-Knee Arteries in Patients With Chronic Limb-Threatening Ischemia: 30-Day Results of the Auryon BTK. Am J Cardiol. 2024 May 15;219:1-8.
7 Das TS, Shammas NW, Yoho JA, Martinez-Clark P, Ramaiah V, Leon LR, Pacanowski JP, Tai Z, Ali V, Arslan B, Rundback J. Solid state, pulsed-wave 355 nm UV laser atherectomy debulking in the treatment of infrainguinal peripheral arterial disease: The Pathfinder Registry. Catheter Cardiovasc Interv. 2024 May;103(6):949-962.
8 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
9 Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644
10 Auryon System Indications for Use
11 Built-in aspiration available only with the 2.0- and 2.35-mm catheters.
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Source: AngioDynamics, Inc.
FAQ
What is the Auryon Atherectomy System by AngioDynamics (ANGO) approved for in Europe?
How many patients has the Auryon System treated in the United States since FDA clearance?
What is the size of the global PAD market that AngioDynamics (ANGO) is targeting with the Auryon System?
What wavelength does the Auryon Atherectomy System use for its laser platform?
