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Endospan Completes Enrollment in TRIOMPHE Trial for NEXUS Aortic Arch Stent Graft

• Endospan has concluded enrollment in the primary arm of the TRIOMPHE study, evaluating the NEXUS stent graft for aortic arch disease treatment. • The NEXUS device, already CE marked in Europe, aims to provide a less invasive, off-the-shelf solution for complex aortic arch pathologies. • The TRIOMPHE trial, conducted across 30 US and one New Zealand site, will monitor patient safety and efficacy for one year. • Early trial results suggest the NEXUS stent graft demonstrates safety in high-risk surgical patients, potentially revolutionizing aortic arch disease treatment.

Endospan has announced the completion of enrollment for the primary arm of the TRIOMPHE (NCT04471909) clinical trial, a significant step toward seeking FDA approval for its NEXUS Aortic Arch Stent Graft. The trial is designed to evaluate the safety and efficacy of the NEXUS device in treating patients with aortic arch disease, a condition affecting over 120,000 individuals annually in the US and Europe. With only a fraction of these cases being diagnosed or treated, the need for innovative solutions is critical.

TRIOMPHE Trial Details

The TRIOMPHE study, conducted under an FDA investigational device exemption (IDE), enrolled 110 patients across 30 clinical sites in the US and one in New Zealand. The trial includes three arms, each focusing on different aortic arch pathologies: chronic dissection, aneurysm, and penetrating aortic ulcer with intramural hematoma. The primary endpoint assesses device technical and clinical failures within 30 days post-procedure.

NEXUS Aortic Arch Stent Graft

The NEXUS stent graft is designed as an off-the-shelf system for endovascular repair of the aortic arch. It features a cranial narrow end intended for deployment into the brachiocephalic artery and a distal end placed in the descending thoracic aorta. The device received CE marking in Europe in 2019, indicating its prior approval for use in the European market.

Expert Perspectives

Dr. Brad Leshnower, the national cardiac principal investigator for the TRIOMPHE study, noted that early results have demonstrated safety for NEXUS in a high-risk surgical cohort, with a low rate of stroke. Dr. Ross Milner, the vascular principal investigator, believes NEXUS has the potential to "revolutionize the treatment of aortic arch disease," offering a less invasive alternative to traditional open surgery.

Market Context

The global aortic stent graft market is substantial, estimated at $3.1 billion last year and projected to reach $4.4 billion by 2033. Endospan's efforts to bring the NEXUS device to the US market are supported by a $25 million funding agreement with Artivion, aimed at advancing the trial and securing FDA approval. Key players in the aortic stent graft market include Gore (with nearly 60% market share), Medtronic, and Cook Medical.
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Highlighted Clinical Trials

NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

NCT04471909RecruitingNot Applicable
Endospan Ltd.
Posted 10/20/2020

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Reference News

[1]
Endospan completes enrollment in aortic arch stent graft study - MassDevice
massdevice.com · Oct 22, 2024

Endospan completed enrollment for TRIOMPHE IDE trial, evaluating Nexus aortic arch stent graft. The trial, across 30 U.S...

[2]
Endospan hits enrolment milestone in aortic arch stent trial - Medical Device Network
medicaldevice-network.com · Oct 21, 2024

Endospan completes enrollment in TRIOMPHE study, evaluating NEXUS stent graft for aortic arch disease under FDA IDE. The...

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