Endospan’s Nexus aortic arch stent graft system received FDA breakthrough device designation in April.
The Nexus system allows for a minimally invasive approach to aortic arch repair, including aneurysms and dissections. An investigational device exemption (IDE) study for the Nexus stent-graft system is set to start enrolling patients later in 2020. The breakthrough designation will also allow a prioritized FDA review of a subsequent pre-market approval application at the conclusion of the study to seek the agency’s nod to commercialize the device in the U.S., according to CEO Kevin Mayberry.
Endospan in September last year signed a distribution agreement with CryoLife for the Nexus system. CryoLife agreed to pay $10 million upfront and provide up to $15 million in debt financing to Endospan, subject to U.S. clinical development.