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).…
- GMDN category: Graft, vascular, synthetic
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.