Israel’s Endospan has received US Food and Drug Administration (FDA) approval for the NEXUS aortic graft stent system, priming the company for the US commercialisation of the aortic arch dysfunction treatment.
Nexus is designed for treating high-risk surgical patients with aortic arch disease, which includes conditions such as chronic dissections of the aorta or aortic arch syndrome. The aorta, a cane-shaped vessel that circulates blood from the lower-left part of the heart, is the largest blood vessel in the human body.
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Designed to mimic the ascending and arch anatomy, Nexus features a pre-shaped catheter that Endospan says is intended to minimise arch manipulation.
Aortic dissection occurs when the inner layer of the aortic wall tears, a situation that causes the inner and middle layers of the aorta to fill with blood, thereby weakening the wall of the aorta. The build-up of pressure due to this condition can lead to rupture.
Meanwhile, aortic arch syndrome affects the great arteries that branch from the aortic arch, resulting in diminished blood supply to the areas supplied by these vessels.
Endospan’s FDA approval was supported by data from the company’s TRIOMPHE (NCT04471909) clinical study that evaluated the treatment of thoracic aortic lesions involving the aortic arch, with a native or previously implanted surgical graft in the ascending aorta (the beginning region of the aorta vessel located in the heart).
Results at the one-year point for Nexus’s application in the high-risk surgical patients with chronic dissections demonstrated safe and effective treatment in the ascending aorta.
Endospan CEO, Kevin Mayberry, highlighted that on the basis of the one-year data from the TRIOPMPHE study, Nexus had demonstrated that its efficacy as a “viable alternative for patients with arch disease”.
Research suggests that over 120,000 patients suffer from aortic arch disease in the US and Europe annually, but only around 25% of patients are diagnosed or treated. According to Endospan, this is due to factors including the fact that patients with excessive risk factors may not be eligible for surgery, while the anatomical complexity of the aorta plays a further role in patients not receiving treatment.
