Endospan completed enrolment for the primary arm of its TRIOMPHE FDA investigational device exemption (IDE) trial. TRIOMPHE evaluates the safety and efficacy of the Nexus aortic arch stent graft for the treatment of aortic arch disease. The company previously said it expected to enrol up to 110 patients with a variety of aortic arch pathologies. The trial takes place across 30 aortic centers in the U.S. and one in New Zealand.
Endospan plans to monitor the patients’ safety and efficacy for 1 year prior to submitting Nexus for FDA approval. The company entered into a $25 million loan agreement earlier this year to progress the technology.
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Nexus, a bi-modular off-the-shelf device, is designed to deliver a minimally invasive solution for patients with aortic arch disease.
Dr. Brad Leshnower, the study’s national cardiac principal investigator, said early results from TRIOMPHE demonstrated safety for Nexus in a high-risk surgical cohort with a low rate of stroke. Dr. Ross Milner, the vascular principal investigator, said Nexus could “revolutionize the treatment of aortic arch disease.” Milner said it provides a less invasive alternative to open surgery.
“We are thrilled to announce the completion of enrolment for the primary arm of this important clinical study,” said Kevin Mayberry, CEO of Endospan. “The Nexus aortic arch stent graft has the potential to significantly improve outcomes for patients with aortic arch disease. We are committed to bringing this innovative technology, which is already a proven platform in Europe, to the U.S. as quickly as possible.”
