Endospan’s Nexus Aortic Arch Stent Graft System Approved by FDA

April 7, 2026—Endospan, an Israel-based developer of solutions for the endovascular repair of aortic arch disease, announced that the FDA has approved the Nexus aortic arch stent graft.

According to the company, Nexus is a bimodular system designed to mimic the ascending and arch anatomy. It has a low-profile 20-F delivery system with a preshaped catheter to allow a single pass into the arch, minimizing arch manipulation, and an integrated branch designed for hemodynamic efficiency.

FDA approval was supported by the 1-year results of the prospective multicenter TRIOMPHE investigational device exemption study, advised Endospan. TRIOMPHE assessed the safety and effectiveness of the Nexus system in patients at high risk for open surgical repair. The company reported that the TRIOMPHE study showed the Nexus system effectively treated aortic arch disease, including chronic aortic dissections, and demonstrated safe and effective treatment in the ascending aorta.

Brad Leshnower, MD, is the TRIOMPHE study’s National Cardiac Principal Investigator, and Ross Milner, MD, is National Vascular Principal Investigator.

“The anatomical design of the Nexus system addresses many of the complexities that occur when treating the ascending and aortic arch,” commented Dr. Leshnower in Endospan’s press release. “I am pleased to now be able to offer this minimally invasive solution to patients with life-threatening diseases involving the ascending aorta and arch who are at high risk for conventional open repair.”

Dr. Milner added, “On behalf of my Coprincipal National Investigator Dr. Leshnower and me, I would like to thank the entire TRIOMPHE investigational body for their commitment, time, and effort to make this technology available and expand our treatment options for delivering aortic care to the community.”

In February, the company announced that the 1-year results of the TRIOMPHE were presented at STS 2026, the 62nd annual meeting of the Society of Thoracic Surgeons

In Europe, Endospan announced CE Mark approval for the Nexus stent graft system in 2019.