Artivion Announces Treatment of First Patient with Arcevo LSA in ARTIZEN Pivotal Trial
Artivion (NYSE: AORT) announced the first patient has been treated in the ARTIZEN pivotal trial evaluating the Arcevo LSA Hybrid Stent Graft System for acute and chronic aortic arch pathologies. The prospective, multicenter, non-randomized study will enroll 132 participants across up to 30 U.S. and European centers, with follow-up to five years and emphasis on 1-year outcomes. Primary combined safety and efficacy endpoints include all-cause mortality, new permanent disabling stroke, new permanent paraplegia/paraparesis, unanticipated aortic reoperation in the treated segment, and left subclavian artery occlusion. Artivion says the trial is intended to support a U.S. PMA submission and estimates an incremental $80 million U.S. market opportunity for Arcevo as soon as 2029.
Artivion (NYSE: AORT) ha annunciato che il primo paziente è stato trattato nello studio pivotale ARTIZEN che valuta il Sistema ibrido stent-graft Arcevo LSA per patologie acute e croniche dell'arco aortico. Lo studio prospettico, multicentrico, non randomizzato recluterà 132 partecipanti in fino a 30 centri negli Stati Uniti e in Europa, con follow-up fino a cinque anni e un focus sugli esiti a 1 anno. Gli endpoint primari di sicurezza ed efficacia combinati includono mortalità per tutte le cause, un nuovo ictus permanente disabilitante, una nuova paraplegia/per paraparesi permanente, una reintervento aortico non previsto nel segmento trattato e l'occlusione dell'arteria succlavia sinistra. Artivion dice che lo studio è inteso a supportare una presentazione PMA statunitense e stima un'opportunità di mercato incrementale di $80 milioni negli Stati Uniti per Arcevo già a partire dal 2029.
Artivion (NYSE: AORT) anunció que se ha tratado al primer paciente en el ensayo pivotal ARTIZEN que evalúa el Sistema híbrido de stent-graft Arcevo LSA para patologías agudas y crónicas del arco aórtico. El estudio prospectivo, multicéntrico y no aleatorizado reclutará 132 participantes en hasta 30 centros en Estados Unidos y Europa, con seguimiento de hasta cinco años y énfasis en los resultados a 1 año. Los criterios primarios de seguridad y eficacia combinados incluyen mortalidad por todas las causas, un nuevo accidente cerebrovascular permanente discapacitante, una nueva paraplejia/paraparesis permanente, una reintervención aórtica no planificada en el segmento tratado y la oclusión de la arteria subclavia izquierda. Artivion dice que el ensayo está destinado a respaldar una solicitud PMA en EE. UU. y estima una oportunidad de mercado incremental de $80 millones para Arcevo tan pronto como 2029.
Artivion (NYSE: AORT)은 급성 및 만성 대동맥 궁 경로질환에 대한 Arcevo LSA Hybrid Stent Graft System를 평가하는 ARTIZEN 중요한 시험에서 최초 환자가 치료되었다고 발표했습니다. 전향적이며 다기관의 비무작위 연구로, 최대 30개 센터의 미국과 유럽에서 132명 참가자를 모집하고, 5년까지의 추적관찰과 1년 결과에 중점을 둡니다. 주요 안전성 및 효능 종합 평가 지표에는 모든 원인으로 인한 사망, 새로운 영구적 마비/신경장애가 있는 뇌졸중, 새로운 영구적 마비/편마비, 치료된 구간에서의 예기치 않은 대동맥 재수술, 좌하대동맥 폐쇄가 포함됩니다. Artivion은 이 시험이 미국 PMA 제출을 지원하기 위한 것이라고 말하며, Arcevo에 대해 2029년부터의 $80백만의 시장 기회가 추가될 것으로 추정합니다.
Artivion (NYSE: AORT) a annoncé que le premier patient a été traité dans l'essai pivot ARTIZEN évaluant le Système hybride de stent-graft Arcevo LSA pour les pathologies aiguës et chroniques de l’arc aortique. L'étude prospective, multicentrique et non randomisée recrutera 132 participants dans jusqu'à 30 centres aux États‑Unis et en Europe, avec un suivi jusqu'à cinq ans et un accent sur les résultats à 1 an. Les critères d'échec et de sécurité et d'efficacité primaires combinés comprennent la mortalité toutes causes confondues, un nouvel AVC permanent invalidant, une nouvelle paraplégie/paraprésie permanente, une réopération aortique non anticipée dans le segment traité et l'occlusion de l'artère subclavière gauche. Artivion indique que l'essai est destiné à soutenir une soumission PMA aux États‑Unis et estime une opportunité de marché incrémentale de 80 millions de dollars pour Arcevo dès 2029.
Artivion (NYSE: AORT) gab bekannt, dass der erste Patient im ARTIZEN-Studienzentrum behandelt wurde, das das Arcevo LSA Hybrid Stent Graft System für akute und chronische Pathologien des Aortenbogens bewertet. Die prospektive, multizentrische, nicht-randomisierte Studie wird 132 Teilnehmer in bis zu 30 US- und europäischen Zentren einschreiben, mit Follow-up bis zu fünf Jahren und Schwerpunkt auf 1-Jahres-Ergebnissen. Zu den primären kombinierten Endpunkten für Sicherheit und Wirksamkeit gehören die Mortalität jeglicher Ursache, ein neuer permanenter behindernder Schlaganfall, eine neue permanente Paraplegie/Paraparesis, eine unerwartete aortale Reoperation im behandelten Segment und die Occlusion der linken Subclavia. Artivion sagt, dass die Studie dazu bestimmt ist, eine US-PMA-Einreichung zu unterstützen, und schätzt eine inkrementelle Marktchance von $80 Millionen für Arcevo, sobald 2029 erreicht ist.
Artivion (NYSE: AORT) أعلنت أن أول مريض عُولج في تجربة ARTIZEN المحورية التي تقيم نظام Arcevo LSA Hybrid Stent Graft للشرايين القوسية للأبهر الحاد والمزمن. الدراسة prospective، متعددة المراكز، غير العشوائية ستضم 132 مشاركاً عبر ما يصل إلى 30 مركزاً في الولايات المتحدة وأوروبا، مع متابعة حتى خمس سنوات وبتركيز على النتائج بعد سنة. تشمل نقاط النهاية الأساسية المجمَّعة للسلامة والفعالية الوفيات من جميع الأسباب، سكتة دماغية دائمة جديدة مع عجز، شلل دائم جزئي/مُربك، إعادة جراحة أبْهُتُ غير متوقعة في الجزء المعالج و انسداد الشريان الفرعي الأيسر. تزعم Artivion أن الاختبار مقصود منه دعم تقديم PMA في الولايات المتحدة وتقدِّر وجود فرصة سوقية متزايدة بمقدار $80 مليون في الولايات المتحدة لـ Arcevo في أقرب وقت من 2029.
- First patient treated in ARTIZEN pivotal trial
- Trial to enroll 132 patients across up to 30 centers
- Study supports a planned PMA submission in the U.S.
- Company estimates an incremental $80M U.S. market opportunity by 2029
- Trial is non-randomized, which may limit comparative evidence strength
- PMA and commercial upside are contingent on trial success and timing to 2029
Insights
First-patient treated in the ARTIZEN pivotal trial advances regulatory pathway toward a U.S. PMA and the stated
The trial enrolls 132 participants across up to 30 centers and follows each subject for up to
Key dependencies include recruitment pace, event rates for the combined primary endpoint, and data quality from multicenter sites. Risk factors are typical for non-randomized device trials: potential slow enrollment, variable site experience, and the need for robust adjudication of clinical events. Monitor enrollment cadence, interim safety reviews, primary endpoint outcomes at
The ARTIZEN trial is a prospective, multicenter, non-randomized clinical trial consisting of 132 participants in the
Dr. Eric Roselli, the ARTIZEN Global Principal Investigator, Chief of Adult Cardiac Surgery at the Cleveland Clinic Department of Thoracic and Cardiovascular Surgery, said "Surgery for aortic arch disease is complex, particularly when connecting to the left subclavian artery because of its anatomic location deep in the chest. The Arcevo device is a major advancement that may streamline the operation, making it faster and potentially safer for the patient."
"We are excited to see the first patient be enrolled in the Arcevo IDE trial which represents a positive milestone for the Company, and we look forward to bringing our next generation frozen elephant trunk to more patients in need through the ARTIZEN pivotal trial," said Pat Mackin, Chairman, President and Chief Executive Officer of Artivion. "We estimate a PMA for Arcevo would open an incremental
About the Arcevo LSA ARTIZEN Pivotal Trial
The ARTIZEN trial is a prospective, multicenter, non-randomized clinical trial evaluating the safety and effectiveness of Arcevo LSA in the treatment of acute and chronic aortic arch pathologies. The trial is designed to support the Company's forthcoming application to the
About the Arcevo™ LSA Hybrid Stent Graft System
Arcevo LSA comprises of a self-expanding aortic stent graft with an integrated stented left subclavian artery (LSA) branch, preloaded onto a delivery system engineered for controlled and accurate deployment of the implant into the transected aorta and LSA during a Frozen Elephant Trunk (FET) procedure. Arcevo LSA is the Company's next generation FET device, building on the E-vita® Open Neo Hybrid Stent Graft System, currently available in
The FET procedure is a hybrid surgical approach that combines open surgery with an endovascular stented device to treat extensive aortic disease. The stented LSA branch of the Arcevo LSA device is designed to simplify one of the most challenging steps of the procedure by allowing surgeons to perform a more proximal repair with the main anastomosis in zone 2 and eliminating the need for an LSA anastomosis. This innovative design is intended to reduce circulatory arrest time, minimize bleeding and nerve injury, and ultimately improve patient outcomes in complex aortic arch repair1.
About Artivion, Inc.
Headquartered in suburban
References
- Roselli et al. Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study. JTCVS 2024 September; 168,3:746-756.
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SOURCE Artivion, Inc.
FAQ
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