Primary Arm Enrollment Winds Up in Endospan’s Arch Stent Graft Study

Endospan has finished enrolling patients in the primary arm of its TRIOMPHE Investigational Device Exemption (IDE) clinical study for the NEXUS Aortic Arch Stent Graft. The study is evaluating the safety and efficacy of the device to treat aortic arch disease.

“We are thrilled to announce the completion of enrollment for the primary arm of this important clinical study,” Endospan CEO Kevin Mayberry said. “The NEXUS Aortic Arch Stent Graft has the potential to significantly improve outcomes for patients with aortic arch disease. We are committed to bringing this innovative technology, which is already a proven platform in Europe, to the U.S. as quickly as possible.”

The NEXUS Aortic Arch Stent Graft is a bi-modular off-the-shelf device intended to provide a minimally invasive solution for patients suffering from aortic arch disease. The TRIOMPHE IDE study is a three-arm non-randomized study conducted at 30 aortic centers in the United States and one center in New Zealand, enrolling patients with various aortic arch pathologies.

“We are excited to be part of this groundbreaking study. While the early results from the TRIOMPHE study presented at STS this year suggest that the NEXUS system can be used safely to treat aortic arch disease in a high-risk surgical cohort with a low rate of stroke, we anxiously await the results from the full cohort,” stated Brad Leshnower, M.D., (Emory) the study’s cardiac national principal investigator.

“The NEXUS device has the potential to revolutionize the treatment of aortic arch disease by offering a less invasive alternative to open surgery,” added Ross Milner, M.D., (UChicago), the study’s vascular national principal investigator. “We are eager to see the results of this study regarding midterm durability and patient outcomes.”

The company plans to monitor the patients’ safety and efficacy for one year before submitting the graft for U.S. Food and Drug Administration approval.

Privately held Endospan, headquartered in Herzlia (Tel Aviv), Israel, develops endovascular repair solutions for aortic arch disease, 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 to undergo open-chest surgery with its invasiveness and risks, lengthy hospitalization periods, and prolonged recuperation.

The NEXUS Aortic Arch Stent Graft System is currently available for sale in Europe and is intended for investigational use only in the United States.