Device Dossier

Acuity X4 Spiral L - Lead, pacemaker, implantable, endocardial

Device Dossier for Acuity X4 Spiral L - Lead, pacemaker, implantable, endocardial (Lead, pacemaker, implantable, endocardial, Class III, sponsor Boston…

Intended purpose

Intended for chronic, left-ventricular pacing and sensing via the coronary venous system when used in conjunction with a compatible pulse generator.

Functional description

The ACUITY X4 quadripolar coronary venous leads are intended for chronic left ventricular pacing and sensing. These steroid-eluting leads have an over-the-wire design and an IS41 fourpole connector. A variety of pace/sense configurations are possible with the four distal,IROX-coated electrodes that can function as cathodes (all four electrodes) or anodes (all except E1, the most distal electrode) when used with a compatible pulse generator.

TGA Public Summary