CryoLife receives CE Mark for hybrid stent graft system E-vita Open NEO™

Atlanta: CryoLife, Inc., a leading cardiac and vascular surgery company focused on aortic disease, announced that it has received CE Mark for the E-vita Open NEO, a hybrid stent graft system for the treatment of aortic arch disease.

The aortic arch disease includes both aortic aneurysms and aortic dissections, which occur suddenly and usually without warning. Approximately 7,000 patients are surgically treated for thoracic 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 repaired in a two-stage procedure – one to repair the arch and the next to repair the descending thoracic aorta. The Company's 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, providing a more cost-effective solution for the health system and allowing 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 thoracic stent graft offering, Enya.

"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," remarked Pat Mackin, Chairman, President, and Chief Executive Officer of CryoLife.

PD. Dr. med. Konstantinos Tsagakis and Prof. Dr. med. Arjang Ruhparwar in Essen, Germany commented, "15 years ago, the introduction of the Evita 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 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."

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