Endospan reports encouraging one-year results for aortic arch stent-graft study

Endospan, a privately held company focused on endovascular treatments for aortic arch disease, reported promising one-year results from its TRIOMPHE Investigational Device Exemption study evaluating the NEXUS Aortic Arch Stent-Graft System, according to data presented at the Society of Thoracic Surgeons Annual Meeting.

The prospective, multicenter study enrolled 94 high surgical-risk patients across three study arms to assess the safety and effectiveness of the NEXUS system for treating complex aortic arch conditions, including dissection, aneurysm and penetrating aortic ulcer or intramural hematoma. All patients were treated in Zone 0 of the aortic arch, one of the most challenging areas to repair because of its proximity to major vessels supplying the brain.

“The 12-month data from the TRIOMPHE study are highly encouraging for the treatment of aortic arch disease,” said Brad Leshnower, national cardiac surgery principal investigator. “The sustained low stroke and mortality rates in a very high-risk patient population is a significant achievement.”

According to Endospan, core laboratory analysis showed no Type III or Type IV endoleaks at one year. Only three patients experienced a Type Ia or Ib endoleak, findings that suggest durable sealing of the stent-graft through 12 months.

“As a vascular surgeon, I am excited to see the one-year results from TRIOMPHE continue to mirror the positive results we have seen in the long-term data on NEXUS in Europe,” said Ross Milner, national vascular surgery principal investigator. “It is rewarding to be involved in bringing a less invasive treatment option like NEXUS to patients with complex aortic arch pathologies.”

More than 120,000 patients in the United States and Europe develop thoracic aortic arch disease each year, yet only about one-quarter are diagnosed or treated, Endospan said. Open surgical repair of the aortic arch remains associated with high mortality and morbidity, and many patients are not candidates because of perioperative risk or anatomical complexity.

“NEXUS was designed specifically for the total aortic arch,” said Endospan CEO Kevin Mayberry. “We are pleased to see that the one-year data for the TRIOMPHE study aligns with the pre- and post-commercialization data that has been published in Europe. The TRIOMPHE data continues to support NEXUS as a straightforward, minimally invasive solution for aortic arch repair that allows for procedural consistency with reliable patient outcomes.”

Advances in endovascular repair of the aortic arch

Endospan’s results reflect broader progress in endovascular approaches for treating complex thoracic aortic disease, an area that has historically lagged behind abdominal aortic aneurysm repair because of anatomical and technical challenges.

The aortic arch supplies blood to the brain and upper extremities, making stroke risk a central concern during repair. Traditional open surgery typically requires cardiopulmonary bypass, deep hypothermia and circulatory arrest — techniques that increase the risk of neurologic injury and prolonged recovery, particularly in older or medically fragile patients.

In recent years, device manufacturers and clinicians have focused on developing branched and fenestrated stent-grafts specifically engineered for the arch. These systems aim to preserve blood flow to critical vessels while allowing physicians to treat disease through minimally invasive, catheter-based procedures. Improvements in imaging, delivery systems and procedural planning have also contributed to more consistent outcomes.

Clinical studies from Europe, where some arch-specific devices have been available longer, have demonstrated that endovascular repair can reduce operative times, shorten hospital stays and lower the need for extracorporeal circulation and hypothermia. U.S. investigators have increasingly looked to replicate those results through IDE trials such as TRIOMPHE, which are designed to support regulatory approval while building operator experience.

Despite the progress, significant unmet need remains. Many patients with aortic arch disease still go untreated because of surgical risk, late diagnosis or the absence of approved devices tailored to their anatomy. Experts say continued innovation, longer-term follow-up data and broader physician training will be critical to expanding access to minimally invasive options and improving outcomes for this complex patient population.