Israeli company Endospan has announced the first implant of its NEXUS Aortic Arch Stent Graft System on a patient with a thoracic aortic aneurysm in the TRIOMPHE Study being carried out in Sentara Norfolk General Hospital, Virginia, US.
It is estimated that more than 120,000 patients suffer thoracic aortic arch disease in the US and Europe yearly, but only 25% of them are diagnosed or treated.
Even though minimally invasive, endovascular repair is the standard of care for abdominal aortic aneurysm (AAA), aortic arch disease patients having aneurysms or dissections have no choice other than undergoing invasive open-chest surgery.
The CE Mark-approved system is designed for treating patients diagnosed with a dilative lesion in or near the aortic arch in a minimally invasive manner.
The company noted that minimally invasive repair reduces the need for extracorporal circulation and chances of hypothermia, resulting in a minimal procedure and hospitalisation period.
The multi-arm, multi-centre, non-randomised, prospective clinical study will analyse the safety and effectiveness of NEXUS in treating thoracic aortic lesions, involving the aortic arch.
The company said it will enrol 100 participants at up to 30 sites.
Endospan CEO Kevin Mayberry said: “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.
“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 patient outcomes.”
Last August, Endospan received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to start the TRIOMPHE study on the NEXUS Aortic Arch Stent Graft System.