FDA approved Endospan's NEXUS Aortic Arch Stent Graft System on April 2. The PMA, P250033, covers endovascular treatment of chronic dissections involving the aortic arch in patients at high risk for open repair who have suitable anatomy. FDA received the application on August 22, 2025, a 223-day review, and a post-approval study is required. Endospan and Artivion announced the decision on April 7.
The evidence comes from TRIOMPHE, a prospective multicenter IDE study led by Brad Leshnower as cardiac principal investigator and Ross Milner as vascular principal investigator. At one year, 90% of patients were free from lesion-related death, 90% free from disabling stroke, and 98% free from reintervention for endoleaks. NEXUS has carried a CE mark since 2019, and Artivion has sold it in Europe, the Middle East and Africa since then.
The approval letter is also a trigger. Artivion holds an exclusive option to acquire the 50-person Herzliya company within 90 days of the FDA notice. A $150M delayed-draw term loan is in place to pay for it. Structuring the exit as an option that vests on approval kept Endospan funded through a Class III review. The price gets settled after the regulatory risk is gone.