The US Food and Drug Administration (FDA) has granted Endospan an investigational device exemption (IDE) to start the TRIOMPHE study on the Nexus aortic arch stent graft system (Nexus).
Earlier this year, FDA granted Nexus designation as a breakthrough device. This designation acknowledges the Nexus may provide a more effective treatment for life-threatening or irreversibly debilitating diseases or conditions.
Minimally invasive techniques are standard-of-care for treating descending aortic disease and heart disease, but highly invasive, high-mortality open surgery is still being used in the difficult-to-treat aortic arch anatomy. According to a press release, the Nexus is uniquely engineered to address this significant area of unmet clinical need.
More than 120,000 patients suffer thoracic aortic arch disease every year in the USA and Europe, with only about 25% being diagnosed or treated. This global market opportunity is over US$1.3 billion in a high average selling segment with no other off-the-shelf competition to the Nexus technology.
The prospective and multi-arm pivotal IDE TRIOMPHE study will evaluate in up to 30 centres, the safety and effectiveness of the Nexus for the endovascular treatment of thoracic aortic lesions involving the aortic arch including chronic dissections, aneurysms, penetrating aortic ulcers, and intramural haematoma.
“The TRIOMPHE pivotal study will assess the Nexus in some of the most challenging aortic arch pathologies that we encounter. For the patient, there are limited options to treat these life threatening pathologies. The Nexus device is designed to address most of those complexities through a minimally invasive approach with the potential to provide a safe and durable solution,” indicated the national principal co-investigator, Ross Milner (University of Chicago, Chicago, USA).
Brad Leshnower (Emory University School of Medicine, Atlanta, USA), the national principal co-investigator stated, “There are a significant number of patients who are too high risk for open surgical treatment who are also at significant risk from their aortic arch disease. The Nexus provides an innovative minimally invasive option, which provides cardiac surgeons, if proven safe and effective, the potential to save the lives of patients who would have previously had no other treatment options available.”
Kevin Mayberry, CEO of Endospan added, “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 USA brings us one step closer to our goal of providing an endovascular approach to treat aortic arch disease pathologies.”