Endospan, a company focused on solutions for endovascular repair of aortic arch disease, has earned U.S. Food and Drug Administration (FDA) approval for its Nexus aortic arch stent graft.

Nexus is a bimodular system engineered to mimic the ascending and arch anatomy of the aorta. The company said it boasts the lowest profile 20 Fr delivery system, with a pre-shaped catheter to allows one pass into the arch. This minimizes arch manipulation and offers an integrated branch for hemodynamic efficiency.

The FDA nod was bolstered by one-year results from Endospan’s TRIOMPHE investigational device exemption (IDE) study, which showed effective treatment of aortic arch disease. This included chronic aortic dissections in patients at high risk for open surgical repair.

Further, the results for high-risk patients with chronic dissections demonstrated safe, effective treatment in the ascending aorta. The company said this is a very difficult segment of the aorta to treat without high rates of mortality or stroke.

Over 120,000 patients suffer from thoracic aortic arch disease every year in the U.S. and Europe, Endospan cited, with only about 25% diagnosed or treated. It said anatomical complexity and lack of approved devices for the arch have often prohibited endovascular repair.

“The anatomical design of the NEXUS System addresses many of the complexities that occur when treating the ascending and aortic arch,” said Brad Leshnower, national cardiac surgery co-principal investigator. “I am pleased to now be able to offer this minimally invasive solution to patients with life threatening diseases involving the ascending aorta and arch who are at high risk for conventional open repair.”

“This is an exciting milestone for our team, and we are grateful for the dedication and partnership of all the physicians and clinical staff involved in the TRIOMPHE Study,” added Kevin Mayberry, Endospan’s CEO. “NEXUS was designed specifically for the ascending and aortic arch. The TRIOMPHE one-year data and pre-and-post commercialization data from the EU demonstrate that this is a viable alternative for patients with arch disease and we are pleased, with the FDA approval, to be able to offer NEXUS to U.S. patients.”