Endospan this week said its Nexus aortic arch stent graft system received FDA breakthrough device designation.
The Nexus Stent Graft System allows for a minimally invasive approach to aortic arch repair, including aneurysms and dissections.
“Receiving the breakthrough device designation from FDA acknowledges our novel technology has the potential to provide a unique and innovative endovascular treatment for patients with aortic arch disease,” CEO Kevin Mayberry said in a news release. “This recognition is important for Endospan in that it allows FDA to expedite the review of an Investigational Device Exemption (IDE) study for the Nexus Stent Graft System that is expected to start enrolling patients later in 2020. It will also allow a prioritized review of a subsequent Pre-Market Approval (PMA) application at the conclusion of the study to seek approval to commercialize the device in the U.S.”
Endospan in September last year signed a distribution agreement with CryoLife for the Nexus Stent Graft 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.