FDA approves Endospan’s minimally invasive stent graft for aortic arch disease

Endospan said the U.S. Food and Drug Administration has approved its NEXUS Aortic Arch Stent Graft, a device designed to treat complex aortic arch disease in patients who are at high risk for open surgery.

The approval was supported by one-year results from the TRIOMPHE Investigational Device Exemption study, a prospective, multicenter trial evaluating the safety and effectiveness of the NEXUS system. According to the company, the study demonstrated that the device could safely and effectively treat conditions including chronic aortic dissections in high-risk surgical patients.

The NEXUS system is a bimodular device intended to conform to the anatomy of the ascending aorta and arch. It features a 20F low-profile delivery system and a pre-shaped catheter designed to allow a single pass into the arch, minimizing manipulation. The system also includes an integrated branch aimed at improving blood flow dynamics.

“The anatomical design of the NEXUS system addresses many of the complexities that occur when treating the ascending and aortic arch,” said Brad Leshnower, a national co-principal investigator for the study. He added that the device offers a minimally invasive option for patients with life-threatening disease who face elevated risks with conventional open repair.

The TRIOMPHE trial focused on patients with chronic dissections involving the ascending aorta, a region historically difficult to treat without high rates of complications such as mortality or stroke. Investigators reported favorable safety and efficacy outcomes at one year.

More than 120,000 patients in the United States and Europe are affected by thoracic aortic arch disease annually, according to the company, though only a fraction are diagnosed or treated. Anatomical complexity and a lack of approved endovascular devices for the arch have limited treatment options, particularly for patients who are not candidates for open surgery.

Ross Milner, a co-principal investigator, said the approval expands treatment options for physicians managing complex aortic disease. Company CEO Kevin Mayberry said the milestone enables a U.S. commercial launch of the system.

Recent advances in endovascular treatment of aortic disease

The approval reflects broader momentum in endovascular therapies targeting complex aortic pathology, particularly in anatomically challenging regions such as the ascending aorta and aortic arch.

Historically, open surgical repair has been the standard of care for these conditions, requiring cardiopulmonary bypass and carrying significant risks, especially in older or medically fragile patients. Over the past decade, however, advances in device engineering and imaging have enabled less invasive approaches that reduce procedural morbidity.

One major development has been the evolution of branched and fenestrated stent grafts, which allow clinicians to preserve blood flow to critical branch vessels while excluding diseased segments of the aorta. Improvements in delivery systems — including lower-profile catheters and more flexible designs — have expanded the number of patients eligible for endovascular repair.

Imaging and procedural planning have also advanced. High-resolution CT imaging, three-dimensional modeling and intraoperative navigation tools are helping physicians better understand patient-specific anatomy and optimize device placement. These tools are particularly important in the aortic arch, where curvature and proximity to cerebral vessels increase procedural complexity.

In addition, growing clinical experience and registry data are refining patient selection and procedural techniques. Multidisciplinary “heart team” approaches — combining expertise from vascular surgeons, cardiac surgeons and interventional specialists — are becoming more common in managing complex aortic disease.

While challenges remain, including long-term durability and stroke risk, the continued development of endovascular solutions is reshaping treatment pathways and expanding options for patients who previously had limited or no viable interventions.