Device Dossier

XFINE Re-intervention Kit - Pacing/defibrillation lead stylet

Device Dossier for XFINE Re-intervention Kit - Pacing/defibrillation lead stylet (Pacing/defibrillation lead stylet, Class III, sponsor Microport Crm).…

Intended purpose

The XFINE re-intervention kit is intended to be used with the XFINE leads family only and provides additional accessories at implant or re-intervention: ― The suture sleeve, to secure the lead in place. ― The vein lifter, to aid venous insertion of the lead. ― The funnel, to facilitate stylet insertion into IS-1 lead connector. ― The stylet, to provide additional stiffness and controlled flexibility for manoeuvring the lead into position. It provides an aid for stiffening the lead and allowing lead insertion into the vein, lead advancement through the vessels and lead positioning at the implant site inside the heart chamber.

Functional description

The XFINE re-intervention kit is intended to be used with XFINE leads only and contains additional accessories required during implantation or re-intervention.

TGA Public Summary