Cardiac and vascular surgery company CryoLife has secured CE mark approval for its E-vita Open NEO hybrid stent graft system to treat aortic arch disease.
Aortic arch disease is comprised of both aortic aneurysms and aortic dissections, which result suddenly and frequently without warning.
According to the company, around 7,000 patients are surgically treated for thoracic aortic arch disease per annum in Europe, the Middle East and Africa.
A significant number of patients with either an aneurysm or dissection in the aortic arch also face a dissected or aneurysmal descending thoracic aorta.
CryoLife’s hybrid stent graft technologies facilitate a one-stage procedure treatment
CryoLife’s hybrid stent graft technologies, including E-vita Open NEO and the E-vita Open Plus, facilitate a one-stage procedure treatment by combining the surgical arch repair and endovascular descending thoracic repair.
The system is said to be a cost-effective solution for the health system, as well as helps the patient to avoid a second surgery.
CryoLife also said that the E-vita Open NEO is anticipated to be used in combination with JOTEC’s thoracic stent graft product E-nya.
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.”
In February, CryoLife secured CE mark approval for the On-X Ascending Aortic Prosthesis (AAP).
Based in suburban Atlanta of Georgia, CryoLife I is involved in the manufacturing, processing and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair. The company markets its products in over 100 countries across the world.
