CryoLife Inc. (NYSE:CRY) this week said it won CE mark approval for the E-vita Open NEO hybrid stent graft system to treat aortic arch disease.
The hybrid stent graft technologies allow for a one-stage procedure treatment of this condition by combining the surgical arch repair and endovascular descending thoracic repair.
“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 reduced 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,” president and CEO Pat Mackin said in a news release.
Aortic arch disease can include both aortic aneurysms and aortic dissections, according to the company. They can occur without warning and about 7,000 patients are treated for it annually in Europe.
“Fifteen years ago, the introduction of the Evita Open Plus hybrid stent graft changed conventional open aortic arch surgery,” Drs. Konstantinos Tsagakis and Arjang Ruhparwar in Essen, Germany said. “The device concept is simple – it combines the open surgical approach for the arch with endovascular treatment of the descending thoracic aorta. In our 350 patient experience in Essen, the ability of this device to address the major challenge of this surgery has translated into better outcomes for the patient, including an improved 5-year survival rate. CryoLife’s next-generation hybrid stent graft, the E-vita Open NEO, will continue to advance this procedure by providing surgeons with more options for treating the most complex patient anatomies in a safe and reproducible manner.”