Device Dossier

Axillary Insertion Kit for Impella 5.0 - Vascular introducer kit

Device Dossier for Axillary Insertion Kit for Impella 5.0 - Vascular introducer kit (Vascular catheter introduction set, nonimplantable, Class III,…

Intended purpose

The Axillary Insertion Kit is intended to facilitate Impella pump placement via the axillary artery.

Functional description

The Axillary Insertion Kit contains one introducer set and two graft locks. The graft locks are used to attach a graft onto the introducer. The introducer is used to insert the Impella pump into the left ventricle via the axillary artery.

TGA Public Summary