Device Dossier

Introducer Kit For Impella - Vascular introducer kit

Device Dossier for Introducer Kit For Impella - Vascular introducer kit (Vascular catheter introduction set, nonimplantable, Class III, sponsor Abiomed).…

Intended purpose

The Introducer Kit for Impella is intended to allow access via the femoral artery for insertion of catheters and pacing leads including the Impella series of ventricular assist devices.

Functional description

The introducer set is used to introduce the approved interventional devices into the vasculature. The needle is inserted into the vessel, the guidewire is then introduced through the needle hub and the sheath/dilator assembly is threaded over the guidewire into the vessel after removal of the needle. Once in the desired position, the guidewire and dilator are removed and the introducer sheath stay in place so that the interventional device can be introduced.

TGA Public Summary