Endovascular Stent Graft Enables Minimally Invasive Aortic Arch Repair

Many individuals are not candidates for surgery, and endovascular options for this anatomy have been limited. A newly approved endovascular system now offers a minimally invasive option for select high‑risk patients with aortic arch disease.

Endospan’s NEXUS Aortic Arch Stent Graft System has received U.S. Food and Drug Administration (FDA) approval, supported by one‑year results from the TRIOMPHE Investigational Device Exemption study. The approval enables a U.S. commercial launch of the NEXUS System. The device is intended to treat aortic arch disease, including chronic aortic dissections, in patients at high risk for open surgical repair.

The NEXUS System is a bimodular construct designed to mimic ascending aorta and arch anatomy. Its 20F delivery system incorporates a pre‑shaped catheter intended to allow a single pass into the arch and reduce manipulation within this region. An integrated branch is engineered for hemodynamic efficiency within the arch.

TRIOMPHE is a prospective, multicenter trial evaluating the safety and effectiveness of the NEXUS System in high‑risk surgical patients. One‑year results in patients with chronic dissections demonstrated safe and effective treatment in the ascending aorta, a segment recognized as difficult to manage due to the risk of mortality or stroke. These findings formed part of the evidence package supporting approval.

More than 120,000 patients in the United States and Europe suffer from thoracic aortic arch disease each year, with only about one quarter diagnosed or treated. Anatomical complexity and the historic lack of approved arch devices have limited endovascular options for many patients. Offering a transcatheter alternative may broaden therapeutic choices for the aortic care community.

“The anatomical design of the NEXUS System addresses many of the complexities that occur when treating the ascending and aortic arch,” said Brad Leshnower, national cardiac surgery co‑principal investigator. “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.”

“This is an exciting milestone for our team, and we are grateful for the dedication and partnership of all the physicians and clinical staff involved in the TRIOMPHE Study,” said Kevin Mayberry, CEO. “NEXUS was designed specifically for the ascending and aortic arch. The TRIOMPHE one‑year data and pre‑and‑post commercialization data from the EU demonstrate that this is a viable alternative for patients with arch disease and we are pleased, with the FDA approval, to be able to offer NEXUS to U.S. patients.”

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