Device Dossier
eSheath+ Introducer Set - Vascular introducer kit
Device Dossier for eSheath+ Introducer Set - Vascular introducer kit (Vascular catheter introduction set, nonimplantable, Class III, sponsor Edwards…
- GMDN category: Vascular catheter introduction set, nonimplantable
Intended purpose
The Edwards eSheath+ introducer set is indicated for the introduction and removal of SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA transcatheter heart valve systems and the Alterra adaptive prestent system into the vascular system.
Functional description
eSheath+ Introducer Set contains an expandable sheath (eSheath+) that provides access into the target vessel while maintaining hemostasis and temporarily enlarges its diameter to allow for passage of a device and an introducer with hydrophilic coating that is used to facilitate entry and trackability of the sheath into the vessel, a dilator with hydrophilic coating that is used to dilate the vessel to accommodate the sheath, an expansion tool to pre-expand the sheath during device preparation.