Device Dossier

E-Vita Open Neo - Graft, vascular, synthetic

Device Dossier for E-Vita Open Neo - Graft, vascular, synthetic (Graft, vascular, synthetic, Class III, sponsor Cryolife Medical (Australia) Company).…

Intended purpose

E-vita OPEN NEO is intended for the surgical treatment of dissections or aneurysms in the aortic arch and the descending thoracic aorta with or without involvement of the ascending aorta.

Functional description

The E-vita OPEN NEO implant consists of a vascular graft part and a stent graft part. The vascular graft part of the E-vita OPEN NEO implant has circular crimps that provide the neces-sary form stability and allow to longitudinal stretching for adaption to the anatomy. At the vascular graft part, there is a perfusion branch which may be used for the extracorporeal perfusion during the intervention.

TGA Public Summary