Endospan secured breakthrough device designation from the FDA for NEXUS aortic arch stent graft system at the beginning of this year
Israel-based Endospan has secured an investigational device exemption (DE) approval from the US Food and Drug Administration (FDA) to commence a pivotal study of the NEXUS aortic arch stent graft system.
At the starting of this year, the company secured breakthrough device designation from the FDA for the NEXUS aortic arch stent graft system.
The prospective and multi-arm pivotal IDE TRIOMPHE trial has been designed to assess the safety and efficacy of the NEXUS system for the endovascular treatment of thoracic aortic lesions involving the aortic arch including chronic dissections, aneurysms, penetrating aortic ulcers and intramural haematoma.
The NEXUS system will be assessed in up to 30 centres
Endospan will evaluate the NEXUS aortic arch stent graft system in the trial at up to 30 centres.
According to the company, minimally invasive techniques are standard-of-care for treating descending aortic disease and heart disease, but invasive and high-mortality open surgery is still being used in the difficult-to-treat aortic arch anatomy.
The NEXUS aortic arch stent graft system has been designed to address this crucial area of unmet clinical need.
The NEXUS system is claimed to be the first endovascular off-the-shelf system with CE mark for the treatment of patients diagnosed with a dilative lesion in, or near the aortic arch.
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 commercialization of NEXUSTM in Europe.
“Starting a pivotal study in the U.S. brings us one step closer to our goal of providing an endovascular approach to treat aortic arch disease pathologies.”
In September 2019, Endospan entered into strategic distribution and credit facility agreements with CryoLife.