Medical Device Network

Endospan hits enrolment milestone in aortic arch stent trial

Endospan is advancing its US trial as it looks to gain FDA approval for its already CE marked device.

Endospan has completed enrollment in the primary arm of a clinical trial evaluating its stent graft for the treatment of aortic arch disease.

The TRIOMPHE study (NCT04471909), being conducted under a US Food and Drug Administration (FDA) investigational device exemption (IDE), is slated to enrol 110 patients with a variety of aortic archpathologies.

The trial comprises three arms classified by condition type – chronic dissection, aneurysm, and penetrating aortic ulcer and/or intramural haematoma.

Israel-headquartered Endospan’s stent graft is called NEXUS and is designed to offer an off-the-shelf system for patients with aortic arch disease. The system comprises a cranial narrow end intended to be deployed into the brachiocephalic artery and a distal end placed into the descending thoracic aorta.

The device, which received CE marking in Europe in 2019 for endovascular repair in the aortic arch, comes in a range of sizes based on the patient’s anatomy. Aortic arch conditions, caused by a variety of factors, eventually block the blood vessels branching off the aorta. More than 120,000 patients suffer thoracic aortic arch disease every year in the US and Europe, with only about 25% diagnosed or treated, according to Endospan.

Endospan’s prospective and non-randomised trial aims to generate data to support a marketing application to the FDA. The study is being conducted across 30 clinical sites in the US and along with a single site in New Zealand, according to a ClinicalTrials.gov entry. The trial’s primary endpoint is device technical failures and clinical failures, both measured 30 days after the procedure.

Endospan’s CEO Kevin Mayberry said: “The NEXUS Aortic Arch Stent Graft has the potential to significantly improve outcomes for patients with aortic arch disease. We are committed to bringing this innovative technology, which is already a proven platform in Europe, to the US as quickly as possible.”

The company raised $25m via a funding agreement with medical device maker Artivion in July this year to help advance the trial and pursue FDA approval.

The global aortic stent graft market was estimated to be worth $3.1bn last year and is forecast to rise to $4.4bn by 2033. Gore is the market leader with nearly a 60% global market share, as per analysis by GlobalData. Medtronic and Cook Medical are the two closest challengers, with around a 13% stake each.