Endospan, the developer of the Nexus Stent Graft System, has announced a funding agreement with medical device company Artivion for up to $25m of additional loans.
The funds are earmarked for the pursuit of the US Food and Drug Administration (FDA) approval for Nexus, an endovascular off-the-shelf system designed to treat aortic arch disease, including both aortic aneurysms and aortic dissection.
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Said to be the first and only approved branched endovascular system for aortic arch disease treatment, Nexus offers an alternative to open-chest surgery, which is known for its invasiveness and associated risks.
It aims to address the specific challenges related to the aortic arch anatomy.
Endospan is currently enrolling patients for the TRIOMPHE IDE Study, which will involve up to 110 patients across up to 31 sites.
TRIOMPHE is a multi-arm, multi-centre, non-randomised, prospective, clinical study. It aims to assess Nexus’ safety and effectiveness in treating thoracic aortic lesions involving the aortic arch.
Endospan said that the 30-day results of the first 22 patients enrolled for the study have been consistent with previous EU clinical studies. This indicated that the Nexus system could offer a reliable and minimally invasive solution for aortic arch repair.
Endospan CEO Kevin Mayberry said: “We’re excited to progress in our IDE study with the FDA and extending options for more patients with aortic arch disease through this agreement with Artivion.
“We share a commitment with Artivion to delivering minimally invasive solutions to help surgeons address the complex challenges of this growing market.”
