Endospan has 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.
The prospective and multi-arm pivotal study will evaluate the safety and effectiveness of the NEXUS for the endovascular treatment of thoracic aortic lesions related to the aortic arch.
These include chronic dissections, aneurysms, penetrating aortic ulcers and intramural hematoma. The study will be conducted in up to 30 centres.
The standard-of-care for treating descending aortic disease and heart disease are usually minimally invasive techniques. However, highly invasive, high-mortality open surgery is used in the difficult-to-treat aortic arch anatomy.
The NEXUS is engineered to address this significant area of unmet clinical need, noted the company.
Over 120,000 patients are estimated to be affected by thoracic aortic arch disease annually in the US and Europe, while 25% among them are diagnosed or treated.
Endospan CEO Kevin Mayberry said: “This is a significant milestone for Endospan in bringing the NEXUS towards US patients. We are very encouraged by the European clinical data and commercialisation of NEXUS in Europe. Starting a pivotal study in the US brings us one step closer to our goal of providing an endovascular approach to treat aortic arch disease pathologies.”
NEXUS was granted breakthrough device designation by the FDA earlier this year. The designation indicates that the NEXUS may offer more effective treatment for life-threatening or irreversibly debilitating diseases or conditions.
The system is currently available for sale in Europe.