CryoLife Wins EU CE Mark For E-vita Open NEO Hybrid Stent Graft

CryoLife, Inc., a company based outside of Atlanta, Georgia, announced this week that it has received the European CE Mark for the E-vita Open NEO, a hybrid stent graft system for the treatment of aortic arch disease.

Aortic arch disease encompasses both aortic aneurysms and aortic dissections, which occur suddenly and could be fatal. According to the release, about 7,000 patients are treated surgically for aortic arch disease annually in Europe, the Middle East, and Africa. Many patients with either an aneurysm or dissection in the aortic arch also present with a dissected or aneurysmal descending thoracic aorta. Often, these two conditions are addressed in a two-stage repair – one to repair the arch and the next to repair the descending thoracic aorta.

CryoLife’s E-vita Open NEO enables surgeons to combine these two procedures into one, which allows patients to avoid a second surgery and provides a more cost-effective solution for hospitals. It is anticipated that the E-vita Open NEO will often be used in combination with JOTEC’s thoracic stent graft offering, E-nya.

“We are pleased to have received CE Mark for E-vita Open NEO™, our newest hybrid stent graft technology for aortic arch and descending thoracic aorta repair,” said Pat Mackin, Chairman, President, and CEO of CryoLife, in a press statement. “This new design features a single tri-branched vessel that enhances ease-of-use and implantation that reduces surgical time and allows for a potentially safer procedure, thereby increasing the likelihood that more patients can benefit from the procedure and patient access to these therapies.”

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