Endospan, a leader in endovascular solutions for the Aortic Arch, has announced the completion of enrollment for the primary arm of its TRIOMPHE Investigational Device Exemption (IDE) clinical study, which evaluates the safety and efficacy of the NEXUS® Aortic Arch Stent Graft for treating aortic arch disease.
The NEXUS Aortic Arch Stent Graft is an innovative bi-modular, off-the-shelf device designed to offer a minimally invasive solution for patients with aortic arch disease. The TRIOMPHE IDE study is a three-arm, non-randomized trial being conducted at 30 leading aortic centers across the United States and one in New Zealand, enrolling patients with various aortic arch pathologies.
“We are thrilled to announce the completion of enrollment for the primary arm of this important clinical study,” said Kevin Mayberry, CEO of Endospan. “The NEXUS Aortic Arch Stent Graft has the potential to significantly enhance outcomes for patients with aortic arch disease. We are committed to bringing this innovative technology, already proven in Europe, to the U.S. as quickly as possible.”
Dr. Brad Leshnower from Emory, the national principal investigator for the study, remarked, “We are excited to be part of this groundbreaking research. Early results from the TRIOMPHE study presented at STS this year suggest that the NEXUS system can be safely used to treat aortic arch disease in high-risk surgical patients with a low stroke rate. We eagerly await the results from the full cohort.”
Dr. Ross Milner from UChicago, the vascular national principal investigator, added, “The NEXUS device has the potential to revolutionize aortic arch disease treatment by providing a less invasive alternative to open surgery. We look forward to seeing the study results regarding midterm durability and patient outcomes.”
The company plans to monitor patient safety and efficacy for one year before submitting for FDA approval.
About Endospan
Endospan, a privately held company based in Herzlia (Tel Aviv), Israel, is a pioneer in endovascular repair for aortic arch diseases, including aneurysms and dissections. The NEXUS® Aortic Arch Stent Graft System is the first endovascular off-the-shelf system with CE Mark approval to treat a significantly underserved patient population diagnosed with dilative lesions in or near the aortic arch. While minimally invasive endovascular repair has become standard care for abdominal aortic aneurysms (AAA), patients with aortic arch diseases have often faced the challenges of open-chest surgery, which entails greater invasiveness, risks, longer hospital stays, and extended recovery times.
