Endospan Releases Early TRIOMPHE IDE Study Results

Endospan is sharing 30-day results of the first 22 patients enrolled in the TRIOMPHE IDE study, a multi-arm, multi-center, non-randomized, prospective, clinical trial to evaluate the safety and effectiveness of NEXUS in treating thoracic aortic lesions involving the aortic arch. The study will enroll 110 patients at up to 31 sites.
 
“We were pleased to see that in this high-risk patient population, the 30-day data for these first 22 patients showed a low mortality rate, no disabling strokes, paraplegia, or renal failure and short ICU and hospital lengths of stay,” said Bradley Leshnower, Director of Thoracic Aortic Surgery at Emory University School of Medicine. “One year data is pending.”
 
More than 120,000 patients suffer thoracic aortic arch disease every year in the United States and Europe, with only about 25% diagnosed or treated. Despite significant advancements, open surgical aortic arch repair maintains high mortality and morbidity. Patients with excessive perioperative risk or anatomical factors are not indicated for surgery, yet anatomical complexity and lack of approved devices for the arch has 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 extra corporal circulation and possibility of hypothermia, translating into reduced procedure and hospitalization time.
 
“NEXUS is designed for total endovascular arch repair to address the specific challenges of the aortic arch anatomy,” Endospan CEO Kevin Mayberry stated. “We are pleased to see this early data aligns with the results achieved during the EU clinical study. This data suggests that NEXUS may provide surgeons with a straightforward, minimally invasive solution for aortic arch repair that allows for procedural consistency with reliable patient outcomes.”
 
Privately-held Endospan, headquartered in Herzlia (Tel Aviv), Israel, develops solutions for 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 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. 
 
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.