The NEXUS Aortic Arch Stent Graft System (Endospan Ltd.) is the first and only CE-marked off-the-shelf endovascular aortic arch branch system, indicated for chronic aortic arch dissection in patients at high surgical risk. It received FDA Breakthrough Device designation in March 2020.
To bring NEXUS to the US market, Endospan needed a pivotal IDE study and a Class Ill PMA submission. In August 2020 it engaged Avania as its CRO partner to design, run, and deliver that program, the TRIOMPHE study.
Download it now to learn:
- The background and challenges of bringing a first-of-kind Breakthrough Device through a Class III PMA pathway with no predicate
- How Avania embedded across seven functional areas to deliver continuity from first patient implant through FDA submission
- The strategy behind a clean BIMO inspection, with FDA reviewing 12,387 pages using AI-assisted analysis and issuing no Form 483
- The results: both co-primary endpoints met and FDA PMA approval achieved for the Endospan NEXUS Aortic Arch Stent Graft System
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