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FDA premarket approval · Endospan · Surgery

NEXUS Aortic Arch System

FDA approves the NEXUS branched stent graft for endovascular repair of aortic arch disease.

CompareArtivion press release
Approved · PMA

NEXUS Aortic Arch System

Endospan · Surgery

Type
Implant
FDA route
Premarket approval (PMA)
Bottom line for your practice
40s read

Patients with aortic arch disease now have an FDA-approved endovascular option in the United States. The supporting trial enrolled a high-risk population.

What it is
A branched endovascular stent graft system for the aortic arch, placed through a minimally invasive approach instead of open-chest surgery.
Indicated for
Patients with aortic arch disease, including chronic aortic dissections; the release does not give the full indications for use.
What changes
The release contrasts NEXUS with open-chest surgery, which it describes as historically the main option for these patients. It does not describe a comparison group in the trial.
Evidence
Design not reportedNEXUS TRIOMPHE IDE trialThe trial showed 90% patient survival from lesion-related death, 90% freedom from disabling stroke at 1 year post treatment, and 98% freedom from reintervention due to endoleaks at one year in a high-risk patient population.The source does not describe a clinical study or its design. Common for cleared devices, which can rest on equivalence to a predicate.
Watch for
The release does not list contraindications, warnings or adverse event rates, and does not state the number of patients studied. Reported outcomes are at one year. The release does not describe the trial's design.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
Premarket approval (PMA). The FDA's most demanding device review, for Class III devices that sustain life or carry the highest risk. It requires valid scientific evidence of safety and effectiveness, usually clinical studies, which are not always randomized.

Clinical summary

NEXUS is a branched endovascular stent graft system approved for minimally invasive treatment of aortic arch disease, including chronic aortic dissections. In the NEXUS TRIOMPHE IDE trial, the company reports 90% patient survival from lesion-related death, 90% freedom from disabling stroke at 1 year and 98% freedom from reintervention due to endoleaks at one year in a high-risk population. The release gives no enrollment number, comparison group or adverse event detail.

From the source 3

Artivion press release

The Artivion press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. ATLANTA, April 7, 2026 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that the U.S. Food and Drug Administration (FDA) has approved the premarket approval application (PMA) for the NEXUS® Aortic Arch System, developed by Endospan Ltd. ("Endospan"), Artivion's long-standing partner.

    Backs · Pathway is PMA; date 2026-04-07 is the announcement date (the release does not give a separate FDA decision date)

  2. NEXUS is a branched endovascular stent graft system approved in the United States for the minimally invasive treatment of aortic arch disease, including chronic aortic dissections, a patient population that has historically had little treatment option but open-chest surgery.

    Backs · Indication: aortic arch disease including chronic aortic dissections; alternative has been open-chest surgery

  3. The FDA's approval is supported by data from the NEXUS TRIOMPHE IDE trial, which demonstrated 90% patient survival from lesion-related death, 90% freedom from disabling stroke at 1-year post treatment, and 98% freedom from reintervention due to endoleaks at one year in a high-risk patient population.

    Backs · 90% survival from lesion-related death, 90% freedom from disabling stroke at 1 year, 98% freedom from reintervention due to endoleaks at one year; high-risk population; trial name

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