Artivion develops, markets and sells a number of products in more than 100 countries around the world. Its offerings land within four groups: aortic stent grafts, surgical sealants, mechanical heart valves and implantable cardiac and vascular human tissue. Its loans aim to accelerate Endospan’s push toward FDA approval for its Nexus stent graft system.
Endospan currently has ongoing enrollment in a TRIOMPHE FDA investigational device exemption (IDE) study for Nexus. It aims to evaluate the safety and effectiveness of Nexus in treating thoracic aortic lesions involving the aortic arch. The company expects to enroll up to 110 patients at up to 31 sites.
According to a news release, early data suggests that Nexus could provide a straightforward, minimally invasive solution for aortic arch repair that allows for procedural consistency with reliable patient outcomes. The system could provide an alternative for those who need open-chest surgery.
“We’re excited to progress in our IDE study with the FDA and extending options for more patients with aortic arch disease through this agreement with Artivion,” Kevin Mayberry, CEO of Endospan, said. “We share a commitment with Artivion to delivering minimally-invasive solutions to help surgeons address the complex challenges of this growing market.”
