Device Dossier

Attain Performa Straight MRI SureScan Model 4398 - Lead, pacemaker, implantable, endocardial

Device Dossier for Attain Performa Straight MRI SureScan Model 4398 - Lead, pacemaker, implantable, endocardial (Lead, pacemaker, implantable,…

Intended purpose

This lead is intended for pacing and sensing in the left ventricle when a compatible cardiac resynchronization system is indicated to treat patients who have experienced, or are at significant risk of developing, symptoms associated with heart failure.

Functional description

The Medtronic Attain Performa Straight MRI SureScan 4398 steroid-eluting, quadripolar electrode, transvenous, over-the-wire LV lead is designed for pacing via a cardiac vein. The lead has been tested for use in the Magnetic Resonance Imaging (MRI) environment.

TGA Public Summary