FDA approves Endospan’s NEXUS Aortic Arch Stent Graft System
The FDA approved Endospan’s NEXUS Aortic Arch Stent Graft, enabling US commercial launch. Approval was supported by one-year TRIOMPHE study results in high-risk surgical patients.
Endospan announced that the U.S. Food and Drug Administration has approved the NEXUS Aortic Arch Stent Graft, enabling commercial launch of the NEXUS System in the US. FDA approval was supported by the one-year results of the TRIOMPHE Investigational Device Exemption Study evaluating the NEXUS System in patients at high risk for open surgical repair.
According to the company press release, the TRIOMPHE study showed the NEXUS System effectively treated aortic arch disease, including chronic aortic dissections, in patients at high risk for open surgical repair. TRIOMPHE is a prospective, multicenter study designed to assess the safety and effectiveness of the NEXUS System in high-risk surgical patients.
The one-year results for the high-risk surgical patients with chronic dissections demonstrated safe and effective treatment in the ascending aorta, a very difficult segment of the aorta to treat without high rates of co-morbidities such as mortality or stroke. The company said pre-and-post commercialization data from the EU demonstrate that this is a viable alternative for patients with arch disease.
The NEXUS System is a bimodular system designed to mimic the ascending and arch anatomy. It has the lowest profile 20F delivery system with a pre-shaped catheter to allow one pass into the arch to minimize arch manipulation and an integrated branch designed for hemodynamic efficiency.
A national cardiac surgery co-principal investigator said the anatomical design of the NEXUS System addresses many of the complexities that occur when treating the ascending and aortic arch, and described it as a minimally invasive solution for patients with life threatening diseases involving the ascending aorta and arch who are at high risk for conventional open repair.