Endospan announced that the U.S. Food and Drug Administration (FDA) has approved the NEXUS Aortic Arch Stent Graft enabling commercial launch of the NEXUS System in the US.

According to the company press release, FDA approval was supported by the one-year results of the TRIOMPHE Investigational Device Exemption (IDE) Study evaluating the NEXUS System shown to effectively treat aortic arch disease, including chronic aortic dissections, in patients at high risk for open surgical 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,” said Kevin Mayberry, 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.”

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.

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 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.”