Endospan today announced the presentation of 30-day results of the statistical Dissection Primary Arm from the TRIOMPHE Investigational Device Exemption (IDE) clinical study evaluating the NEXUS® Aortic Arch Stent-Graft System. The data were presented during the late-breaking trial session at the American Association for Thoracic Surgery (AATS) Annual Meeting in Seattle.
The TRIOMPHE study is a prospective, multicenter, three-arm trial designed to assess the safety and effectiveness of the NEXUS Aortic Arch Stent-Graft System in patients with aortic arch pathologies (Dissection, Aneurysm, PAU/IMH).
It was reported during the session that the 30-day results from the TRIOMPHE study are promising for aortic arch treatment in Zone 0 with the NEXUS Aortic Arch Stent-Graft System. The study results suggest the NEXUS device may be an acceptable alternative to open aortic arch replacement in select patients at high risk for open surgery.
TRIOMPHE (N=54) | |||
Operative Mortality | 0.0% | ||
30-day Mortality | 9.2% (n=5) | ||
Overall Disabling Stroke (Bypass NEXUS) Post Bypass Post NEXUS | 5.6% (n=3) 1.9% (n=1) 3.7% (n=2) | ||
Renal Failure | 0.0% | ||
Paraplegia | 0.0% | ||
*All events are adjudicated by CEC |
Further, core lab analysis of stent-graft sealing shows no Type Ia, no Type Ib and no Type III endoleaks, suggesting good sealing at 30-day.
"The 30-day data from the TRIOMPHE study are highly encouraging for the treatment of aortic arch disease," said Dr. Brad Leshnower, National Cardiac Principal Investigator. "The low stroke rate, in particular, is a significant achievement. This data is very promising while we await 1 year follow up of the study patients."
"As a vascular surgeon, I am excited about the potential of the NEXUS Aortic Arch Stent-Graft to provide a less invasive treatment option for patients with complex aortic arch pathologies," said Dr. Ross Milner, National Vascular Principal Investigator.
"We are very encouraged by the results of the first ever presented data of Endovascular Aortic Arch Repair in Zone 0 in a Pivotal IDE Study," said Kevin Mayberry CEO of Endospan. "We look forward to continue our leadership in clinical development of Aortic Arch repair in the future." The TRIOMPHE study is ongoing, and longer-term follow-up will provide further insights into the safety and effectiveness of the NEXUS Aortic Arch Stent-Graft System.
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