Device Dossier

IMPERIA Delivery System - Transcatheter heart valve prosthesis implantation catheter

Device Dossier for IMPERIA Delivery System - Transcatheter heart valve prosthesis implantation catheter (Transcatheter heart valve prosthesis…

Intended purpose

The Imperia delivery system is intended for transfemoral retrograde implantation of the Allegra Transcatheter Heart Valve (THV).

Functional description

The IMPERIA Delivery System (DS) will be inserted to the vessel through an 18Fr introducer sheath. The catheter shaft has a distal short cartridge of 18F which accommodates the Transcatheter Heart Valve (THV). By winding the release handle, the catheter is retracted and exposes the inflow of the THV, which will start to open. After retracting the catheter up to safety position, the THV is 80% deployed but still attached to the catheter by 3 T bars of the THV.

TGA Public Summary