Endospan has announced the first implant of its Nexus aortic arch stent graft system on a patient in Norfolk, USA, with a thoracic aortic aneurysm as part of the TRIOMPHE investigational device exemption (IDE) study.
The TRIOMPHE study is a multi-arm, multicentre, non-randomised, prospective, clinical study to evaluate the safety and effectiveness of Nexus in treating thoracic aortic lesions involving the aortic arch. The study will enrol 100 patients at up to 30 sites.
“Aortic arch repair has traditionally been one of the most technically challenging areas to repair, “said Jean M Panneton, Vascular Surgery chief and programme director at Eastern Virginia Medical School (EVMS), Norfolk, USA.
“Some of these patients currently do not have many options that do not come with a high degree of risk” confirmed Christopher J Barreiro, cardiothoracic surgeon, Sentara Mid-Atlantic Cardiothoracic Surgeons, Norfolk, USA. “The TRIOMPHE study investigates if Nexus can safely extend minimally invasive, durable interventions to my patients while mitigating the risks of stroke, endoleaks, and migration.”
“With the first patient enrolled in the TRIOMPHE IDE study, Endospan marks the next crucial milestone towards US approval for the Nexus aortic arch repair stent graft system”, said Kevin Mayberry, CEO.
“The Nexus is specifically engineered for total endovascular arch repair to address the specific challenges of the aortic arch anatomy. With this study, we aim to prove the Nexus will provide surgeons a straightforward, minimally invasive solution for aortic arch repair that allows for procedural consistency with reliable patients outcomes.”