Endospan, a pioneer in endovascular solutions for the Aortic Arch, today announced the completion of enrollment for 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 for the treatment of aortic arch disease.
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NEXUS® Aortic Arch Stent Graft System (Photo: Business Wire)
The NEXUS Aortic Arch Stent Graft is a cutting-edge bi-modular off-the-shelf device designed to provide a minimally invasive solution for patients with aortic arch disease. The TRIOMPHE IDE study is a Three-Arm Non-Randomized Study conducted at 30 leading Aortic centers across the United States and one center in New Zealand, enrolling patients with a variety of 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 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 US as quickly as possible."
Brad Leshnower, MD from Emory who is the Cardiac National PI of the Study added, "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."
Ross Milner, MD from UChicago and Vascular National PI commented, "The NEXUS device has the potential to revolutionize the treatment of aortic arch disease by offering a less invasive alternative to open surgery. 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 1 year prior to submitting for FDA approval.
About Endospan
Privately held Endospan, headquartered in Herzlia (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 to treat a greatly underserved group of 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 not been as fortunate and have had little choice but to undergo open-chest surgery with its invasiveness and risks, lengthy hospitalization periods, and prolonged recuperation. For additional information about Endospan, visit their website at www.endospan.com.
NEXUS® Aortic Arch Stent Graft System is currently available for sale in Europe and is intended for investigational use only in the U.S.
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Contacts:
Kevin Mayberry CEO kevin@endospan.com
