AngioDynamics Initiates RECOVER-AV Clinical Trial Assessing AlphaVac F18⁸⁵ System in Treatment of Pulmonary Embolism and Long-Term Functional Outcomes
AngioDynamics, Inc. (NASDAQ: ANGO) has launched the RECOVER-AV clinical trial to evaluate the AlphaVac F18⁸⁵ System for treating acute, intermediate-risk pulmonary embolism (PE) in the European market. This multi-center, multi-national study follows the successful APEX-AV trial in the US, which showed significant improvements in right ventricular function and clot burden reduction.
The RECOVER-AV trial will enroll patients across up to 20 European hospital sites, focusing on the reduction of the right ventricular/left ventricular ratio and major adverse events. Patients will be followed for 12 months to assess functional outcomes. This study is significant given the higher prevalence and acuity of PE in Europe compared to the US.
The AlphaVac F18⁸⁵ System recently received CE Mark approval in Europe for non-surgical removal of thrombi or emboli from pulmonary arteries. The trial is led by renowned experts in vascular medicine and cardiology, supported by an international Scientific Advisory Board.
AngioDynamics, Inc. (NASDAQ: ANGO) ha lanciato il trial clinico RECOVER-AV per valutare il System AlphaVac F18⁸⁵ per il trattamento dell'embolia polmonare acuta a rischio intermedio nel mercato europeo. Questo studio multicentrico e multinazionale segue il successo del trial APEX-AV negli Stati Uniti, che ha dimostrato significativi miglioramenti nella funzione ventricolare destra e nella riduzione del carico di trombi.
Il trial RECOVER-AV arruolerà pazienti in fino a 20 ospedali europei, focalizzandosi sulla riduzione del rapporto tra il ventricolo destro e sinistro e sugli eventi avversi maggiori. I pazienti saranno seguiti per 12 mesi per valutare gli esiti funzionali. Questo studio è significativo considerando la maggiore prevalenza e gravità dell'embolia polmonare in Europa rispetto agli Stati Uniti.
Il System AlphaVac F18⁸⁵ ha recentemente ricevuto l'approvazione CE in Europa per la rimozione non chirurgica di trombi o emboli dalle arterie polmonari. Il trial è guidato da esperti rinomati in medicina vascolare e cardiologia, supportato da un Consiglio Consultivo Scientifico internazionale.
AngioDynamics, Inc. (NASDAQ: ANGO) ha lanzado el ensayo clínico RECOVER-AV para evaluar el Sistema AlphaVac F18⁸⁵ para el tratamiento de la embolia pulmonar aguda de riesgo intermedio en el mercado europeo. Este estudio multicéntrico y multinacional sigue al exitoso ensayo APEX-AV en los Estados Unidos, que mostró mejoras significativas en la función del ventrículo derecho y en la reducción de la carga de coágulos.
El ensayo RECOVER-AV inscribirá pacientes en hasta 20 hospitales europeos, centrándose en la reducción de la relación ventrículo derecho/vientrículo izquierdo y eventos adversos mayores. Se seguirá a los pacientes durante 12 meses para evaluar los resultados funcionales. Este estudio es significativo dado la mayor prevalencia y gravedad de la embolia pulmonar en Europa en comparación con los Estados Unidos.
El Sistema AlphaVac F18⁸⁵ recibió recientemente la aprobación CE en Europa para la eliminación no quirúrgica de trombos o émbolos de las arterias pulmonares. El ensayo está dirigido por expertos reconocidos en medicina vascular y cardiología, apoyado por un Consejo Asesor Científico internacional.
AngioDynamics, Inc. (NASDAQ: ANGO)는 유럽 시장에서 중간 위험의 급성 폐색전증(PE) 치료를 위해 AlphaVac F18⁸⁵ 시스템을 평가하는 RECOVER-AV 임상 시험을 시작했습니다. 이 다기관 다국적 연구는 미국에서 시행된 APEX-AV 임상 시험의 성공에 이어 진행되며, 우심실 기능과 혈전 부하 감소에서 상당한 개선을 보여주었습니다.
RECOVER-AV 시험은 최대 20개의 유럽 병원에서 환자를 모집하여 우심실/좌심실 비율 감소와 주요 부작용에 초점을 맞출 것입니다. 환자는 기능적 결과를 평가하기 위해 12개월 동안 추적 관찰됩니다. 이 연구는 유럽에서 PE의 유병률과 중증도가 미국에 비해 높다는 점에서 중요합니다.
AlphaVac F18⁸⁵ 시스템은 최근 유럽에서 폐동맥에서 혈전이나 색전 제거를 위한 비수술적 방법에 대해 CE 마크 승인을 받았습니다. 이 시험은 혈관 의학 및 심장학 분야의 저명한 전문가들에 의해 진행되며, 국제 과학 자문 위원회의 지원을 받습니다.
AngioDynamics, Inc. (NASDAQ: ANGO) a lancé l'essai clinique RECOVER-AV pour évaluer le Système AlphaVac F18⁸⁵ pour le traitement de l'embolie pulmonaire aiguë à risque intermédiaire sur le marché européen. Cette étude multicentrique et multinationale fait suite à l'essai APEX-AV réussi aux États-Unis, qui a montré des améliorations significatives de la fonction du ventricule droit et une réduction de la charge thrombotique.
L'essai RECOVER-AV accueillera des patients dans jusqu'à 20 hôpitaux européens, en se concentrant sur la réduction du rapport ventricule droit/ventricule gauche et des événements indésirables majeurs. Les patients seront suivis pendant 12 mois pour évaluer les résultats fonctionnels. Cette étude est particulièrement significative compte tenu de la prévalence et de la gravité plus élevées de l'embolie pulmonaire en Europe par rapport aux États-Unis.
Le Système AlphaVac F18⁸⁵ a récemment obtenu l'approbation CE en Europe pour le retrait non chirurgical des thrombus ou des emboles des artères pulmonaires. L'essai est dirigé par des experts renommés en médecine vasculaire et en cardiologie, soutenus par un Conseil Consultatif Scientifique international.
AngioDynamics, Inc. (NASDAQ: ANGO) hat die klinische Studie RECOVER-AV ins Leben gerufen, um das AlphaVac F18⁸⁵ System zur Behandlung von akuter, intermediärer Lungenembolie (PE) auf dem europäischen Markt zu evaluieren. Diese multizentrische, multinationale Studie folgt der erfolgreichen APEX-AV-Studie in den USA, die signifikante Verbesserungen in der Funktion des rechten Ventrikels und in der Reduktion der Thrombusbelastung gezeigt hat.
Die RECOVER-AV-Studie wird Patienten in bis zu 20 europäischen Krankenhausstandorten einschreiben und sich auf die Reduktion des Verhältnisses von rechtem zu linkem Ventrikel und schwerwiegenden unerwünschten Ereignissen konzentrieren. Die Patienten werden über einen Zeitraum von 12 Monaten verfolgt, um funktionale Ergebnisse zu bewerten. Diese Studie ist von Bedeutung, da die Prävalenz und Schwere von PE in Europa im Vergleich zu den USA höher sind.
Das AlphaVac F18⁸⁵ System hat kürzlich die CE-Kennzeichnung in Europa für die nicht-chirurgische Entfernung von Thromben oder Emboli aus den Lungenarterien erhalten. Die Studie wird von renommierten Experten in der Gefäßmedizin und Kardiologie geleitet und von einem internationalen Wissenschaftlichen Beirat unterstützt.
- Successful completion of APEX-AV trial in the US with 122 patients
- CE Mark approval for AlphaVac F18⁸⁵ System in Europe
- Expansion into European market with higher PE prevalence
- Collaboration with international experts and renowned Scientific Advisory Board
- None.
The initiation of the RECOVER-AV clinical trial for AngioDynamics' AlphaVac F18⁸⁵ System is a significant development in the treatment of acute, intermediate-risk pulmonary embolism (PE). This multi-center, multi-national study aims to evaluate the safety and efficacy of mechanical thrombectomy in PE patients, focusing on the European market.
Key points to consider:
- The primary efficacy endpoint is the reduction in the RV/LV ratio, a important indicator of right ventricular function improvement.
- The safety endpoint focuses on major adverse events within seven days, addressing immediate risks.
- Long-term functional outcomes will be assessed up to 12 months post-procedure, providing valuable data on the system's lasting effects.
With an estimated
AngioDynamics' initiation of the RECOVER-AV trial represents a strategic move to expand its market presence in Europe. The recent CE Mark approval for the AlphaVac F18⁸⁵ System in Europe paves the way for potential revenue growth in this larger market.
Key financial implications:
- Expanded market opportunity in Europe, where PE prevalence is higher than in the US.
- Potential for increased adoption and sales if the trial demonstrates positive outcomes.
- Investment in clinical research indicates long-term commitment to product development and market expansion.
While the immediate financial impact may be due to research costs, successful trial results could lead to significant revenue growth in the medium to long term. Investors should monitor the trial's progress and its potential to influence AngioDynamics' market position in the thrombectomy device sector.
Multi-center, multi-national study to evaluate mechanical thrombectomy treatment in acute, intermediate-risk PE patients in European Market
The RECOVER-AV trial is designed to evaluate the safety and efficacy of AlphaVac for the treatment of acute, intermediate-risk PE to support its adoption in the European market.
This study follows the Acute Pulmonary Extraction Trial with AlphaVac (APEX-AV) study, a single-arm Investigational Device Exemption study that enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in
The RECOVER-AV study is a multi-center, multi-national trial enrolling patients with confirmed acute, intermediate-risk PE across up to 20 hospital sites in
An estimated 435,000 PE events occur each year in the six largest European Union (EU) countries.1 Compared to
“We are excited to launch this important trial as we assess the performance of the AlphaVac F1885 System in patients with intermediate-risk pulmonary embolisms,” said Laura Piccinini, AngioDynamics Senior Vice President and General Manager of Endovascular Therapies and International. “With our clinical partners, we are demonstrating our continued commitment to generating robust clinical evidence across the world, with this being the first international study we have sponsored highlighting our commitment as a global leader to treat more patients and advance care.”
In May, the Company announced that its AlphaVac F1885 System received CE Mark approval in
The Study is led by co-Principal Investigators Erik Klok, MD, Professor of Medicine and Vascular Medicine Specialist at Leiden University Medical Center, and Andrew Sharp, MD, Professor of Interventional Cardiology at Mater Misericordiae Hospital and University College Dublin.
They are supported by an internationally renowned Scientific Advisory Board featuring leading experts in pulmonary embolism (PE) and related fields, including Prof. Menno Huisman (Leiden UMC,
About the AlphaVac F1885 System
The AlphaVac F1885 System is an emergent first-line device that is currently CE marked for the non-surgical removal of thromboemboli from the pulmonary arteries and for the treatment of PE. The System includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly. For risk information, visit https://bit.ly/Angio-risk-info.
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 AlphaVac are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are property of their respective owners.
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1 Willich SN, Chuang LH, van Hout B, Gumbs P, Jimenez D, Kroep S, Bauersachs R, Monreal M, Agnelli G, Cohen A. Pulmonary embolism in |
2 Germini F., Zarabi S., Eventov M., Turcotte M., Li M., de Wit K. Pulmonary embolism prevalence among emergency department cohorts: A systematic review and meta‐analysis by country of study. Journal of Thrombosis and Haemostasis. 2022 Dec; 19(1):173-185 |
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Investor:
Stephen Trowbridge
Executive Vice President & CFO
518-795-1408
strowbridge@angiodynamics.com
Media:
Saleem Cheeks
Vice President, Communications
518-795-1174
scheeks@angiodynamics.com
Source: AngioDynamics, Inc.
FAQ
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