March 4, 2020
CryoLife’s E-vita Open Neo Hybrid Stent Graft Approved in Europe
March 4, 2020—CryoLife, Inc. announced that it has received European CE Mark approval for the E-vita Open Neo, a hybrid stent graft system for the treatment of aortic arch disease, including both aortic aneurysms and aortic dissections.
The company explained that many patients with either an aneurysm or dissection in the aortic arch also present with a dissected or aneurysmal descending thoracic aorta. These two conditions are treated in a two-stage procedure: one to repair the arch and another to repair the descending thoracic aorta.
The CryoLife hybrid stent graft technologies, which include the E-vita Open Neo and the E-vita Open Plus, enable a one-stage procedure treatment of this condition by combining the surgical arch repair and the endovascular descending thoracic repair. According to the company, this provides a more cost-effective solution and allows the patient to avoid a second surgery.
It is anticipated that the E-vita Open Neo often will be used in combination with Jotec’s E-nya thoracic stent graft. Jotec was acquired by CryoLife in 2017.
In CryoLife’s announcement, Professors Konstantinos Tsagakis, MD, and Arjang Ruhparwar, MD, of Essen, Germany, commented, “Fifteen years ago, the introduction of the E-vita Open Plus hybrid stent graft changed conventional open aortic arch surgery. The device concept is simple—it combines the open surgical approach for the arch with an 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.”
Professors Tsagakis and Ruhparwar continued, “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.”