Endospan is sharing positive one-year results of its TRIOMPHE Investigational Device Exemption (IDE) Study, which is evaluating the company’s NEXUS Aortic Arch Stent-Graft System.

TRIOMPHE is a prospective, multicenter, three-arm trial designed to assess the safety and effectiveness of the NEXUS System in patients with aortic arch pathologies (dissection, aneurysm, PAU/IMH). The one-year results for the 94 high surgical risk patients in the three arms are promising for aortic arch treatment in Zone 0, a very difficult aorta segment to treat without high co-morbidity rates such as mortality or stroke.

“The 12-month data from the TRIOMPHE study are highly encouraging for the treatment of aortic arch disease,” said Dr. 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.”

The company recently shared the following highlights.

Further, core lab analysis of stent-graft sealing shows no Type III or IV endoleaks, and only three patients had a Ia or Ib endoleak, suggesting good sealing 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 Dr. 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 suffer from thoracic aortic arch disease annually in the United States and Europe, with only about 25% diagnosed or treated. Despite significant advancements, open surgical aortic arch repair has high mortality and morbidity rates. Patients with excessive perioperative risk or anatomical factors are not indicated for surgery, yet anatomical complexity and lack of approved devices for the arch have often prohibited endovascular repair. This makes the choice of treatment difficult or even impossible for some patients. Providing the alternative of minimally invasive repair decreases the requirement for extracorporeal circulation and the possibility of hypothermia, translating into reduced procedure and hospitalization time.

“NEXUS was designed specifically for the total aortic arch,” Endospan CEO Kevin Mayberry stated. “We are pleased to see 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.”

The NEXUS Aortic Arch Stent-Graft System is pending U.S. Food and Drug Administration PMA review; the process includes a thorough, multi-stage, in-depth evaluation of available safety and efficacy data. The device’s availability outside the United States is subject to local regulations and guidelines.

Privately held Endospan, headquartered in Herzliya (Tel Aviv), Israel, is a pioneer in the endovascular repair of aortic arch disease, including aneurysms and dissections. Endospan’s NEXUS Aortic Arch Stent-Graft System is the first endovascular off-the-shelf system with CE Mark approval to treat patients diagnosed with a dilative lesion in or near the aortic arch. While minimally invasive endovascular repair has been the standard of care for abdominal aortic aneurysm (AAA), aortic arch disease patients with aneurysms or dissections have had little choice but to undergo open-chest surgery.