April 20, 2020
Endospan's Nexus Aortic Arch Stent Graft System Granted FDA Breakthrough Device Designation
April 20, 2020—Endospan announced it was recently granted Breakthrough Device designation from the FDA for the Nexus aortic arch stent graft system.
The FDA’s Breakthrough Device Designation Program is intended to provide timely access to medical devices that have the potential to provide a more effective treatment for life-threatening or irreversibly debilitating diseases or conditions by prioritizing review of its regulatory submissions, thereby expediting the device development process.
Kevin Mayberry, CEO of Endospan, commented in the announcement that the Breakthrough Device designation allows the FDA to expedite the review of an investigational device exemption study for the Nexus stent graft system that is expected to start enrolling patients later in 2020. It will also allow prioritized review by the FDA of a subsequent premarket approval application at the conclusion of the study.
In March 2019, Endospan announced that the off-the-shelf Nexus endovascular device received European CE Mark approval to treat patients diagnosed with a dilative lesion in or near the aortic arch.