Cardiac and vascular surgery company CryoLife has secured CE Mark for its hybrid stent graft system, E-vita Open NEO.
The system helps to treat aortic arch disease, which includes aortic aneurysms, as well as aortic dissections that occur instantaneously without symptoms.
Every year, around 7,000 patients receive surgical treatment for thoracic aortic arch disease in Europe, the Middle East and Africa.
Many patients having an aneurysm or dissection in the aortic arch also acquire a dissected or aneurysmal descending thoracic aorta.
The treatment of these conditions often involves a two-stage procedure, one to repair the arch and the next to restore the descending thoracic aorta.
CryoLife’s hybrid stent graft technologies, which include the E-vita Open NEO and the E-vita Open Plus, provide one-stage procedure treatment for such conditions.
These technologies, which combine the surgical arch repair and the endovascular descending thoracic repair, deliver a cost-effective solution for the health system and enable the patient to avoid a second surgery.
CryoLife chairman, president and CEO Pat Mackin said: “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.
“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.”
CryoLife anticipates that the E-vita Open NEO will be used together with JOTEC’S thoracic stent graft offering, E-nya in the treatment of aortic arch disease.
Last month, the company’s On-X Ascending Aortic Prosthesis (AAP) secured CE Mark, enabling its resumed redistribution in Europe.