Device Dossier

Situs LDS II Lead Delivery System - Catheter introducer, haemostasis valve

Device Dossier for Situs LDS II Lead Delivery System - Catheter introducer, haemostasis valve (Catheter introducer, haemostasis valve, Class III, sponsor…

Intended purpose

The Situs LDS2 is intended for the introduction of various pacing leads or catheters into the coronary sinus.

Functional description

The Situs LDS II is designed to facilitate placement of left ventricular pacing leads into the coronary sinus. The Situs LDS II Lead Delivery System is introduced into the selected vein and positioned with the assistance of fluoroscopy to the patient's coronary sinus. A pacing lead is introduced through the guiding catheter and correctly positioned in the coronary sinus. Once correct lead position is determined, the guiding catheter system is removed utilising the slitter provided.

TGA Public Summary