HERZLIA, Israel--(BUSINESS WIRE)--Endospan, a pioneer in off-the-shelf EndoVascular Aortic Repair (EVAR), announced today that it has received CE marking for its HORIZON Stent Graft System to treat Abdominal Aortic Aneurysm (AAA).
“HORIZON is a unique platform that can be used in a 14Fr single-sided approach, generally shortening and simplifying EVAR procedures,” said Kevin Mayberry, CEO. “HORIZON is supported by a strong cohort of pivotal trial data with over three years of follow-up to support the commercialization effort.
“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 commercialize the HORIZON system for AAA repair,” added Mayberry.
Privately held Endospan, headquartered in Herzlia (Tel Aviv), Israel, is a pioneer in the endovascular repair of Aortic Arch Disease including aneurysms and dissections. Endospan has initiated the CE-marking regulatory process to market in Europe the NEXUS™ Stent Graft System, the first endovascular off-the-shelf system to treat Aortic Arch Disease: a greatly underserved group of patients diagnosed with a dilative lesion in, or near, the aortic arch. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA), 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 hospitalization periods, and prolonged recuperation.
CAUTION: The HORIZON™ Stent Graft System is approved for sale in Europe. The NEXUS™ Stent Graft System is approved for investigational use in Europe, and the CE mark registration process is underway in Europe.