Horizon stent graft receives CE mark

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The Horizon stent graft system, developed to treat abdominal aortic aneurysms, has received CE mark. The stent graft system is produced by Endospan, a company specialising in off-the-shelf endovascular aortic repair (EVAR).

“Horizon is a unique platform that can be used in a 14F single-sided approach, generally shortening and simplifying EVAR procedures,” said Kevin Mayberry, CEO of Endospan. “Horizon is supported by a strong cohort of pivotal trial data with over three years of follow-up to support the commercialisation effort.

In 2016, Vascular News spoke to Mario Lachat (University of Zurich, Zurich, Switzerland) at the VEITH Symposium about the concepts behind the Horizon stent graft as well as the Nexus stent graft, and whether these translate to clinical success. “Single-access site is a key feature of [the Horizon] device, which is really innovative”, Lachat said at the time,  adding that “the results in clinical trials are very promising, and I would guess they get approval for this device based on these results very soon”. Watch the full interview here.

“We are very proud to have earned CE mark in a challenging regulatory environment. Now, with CE mark in hand, we are looking forward to working with potential partners to commercialise the Horizon system for abdominal aortic aneurysm repair,” Mayberry said in a recent statement.

Endospan has also initiated the CE-marking regulatory process to market in Europe their Nexus stent graft system, an endovascular off-the-shelf system for treatmeant of aortic arch disease. While minimally invasive endovascular repair has been the standard of care for abdominal aortic aneurysm, the company states that aortic arch disease patients with aneurysms or dissections have not been as fortunate and have had little choice but to undergo open-chest surgery with its invasiveness and risks, lengthy hospitalisation periods, and prolonged recuperation.

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