FDA approves Israeli Endospan's NEXUS stent graft for aortic arch repair without open surgery

The US Food and Drug Administration approved the NEXUS Aortic Arch Stent Graft System, made by the Israeli company Endospan, on 7 April 2026. The device is meant for people with complex disease of the aortic arch, including chronic dissections of the ascending aorta, who are at high risk if they undergo open surgery. Just over a month later, on 18 May, the American heart-valve and aortic device company Artivion completed its purchase of Endospan for an upfront net price of $135 million, plus further payments tied to sales.

The aortic arch is the curved section of the body's main artery just above the heart, from which the vessels supplying the brain and arms branch off. When it balloons or tears, the standard repair has been open-chest surgery using a heart-lung bypass machine, a punishing operation for older or frail patients. Because of the arch's curve and its branches, ordinary tube-shaped stent grafts could not be used there, which left many patients with no good option. Endospan, citing company estimates, says more than 120,000 people a year in the United States and Europe have thoracic arch disease, though only a fraction are diagnosed or treated.

NEXUS is a two-part stent graft that follows the shape of the ascending aorta and arch and includes a built-in branch to keep blood flowing to the head. It is delivered through a slim catheter that is pre-shaped to enter the arch in one pass, reducing handling of the diseased vessel. Approval rested on one-year results of the TRIOMPHE trial, a multicentre US study in high-risk patients, which the investigators described as showing favourable safety and effectiveness. Questions about long-term durability and stroke risk still need follow-up. The device already had a CE Mark in Europe, where Endospan describes it as the first off-the-shelf endovascular system for the arch.

Endospan, a privately held company based in Herzliya, had worked with Artivion since 2019, when Artivion became the exclusive distributor of NEXUS in Europe, the Middle East and Africa. Artivion chief executive Pat Mackin called NEXUS a platform technology rather than a single product, and said the deal completed the company's portfolio of aortic arch treatments.