OmniaSecure™ SureScan™ MRI lead - Lead, defibrillator, implantable

Intended purpose

The Model 3930M lead is intended for single use in the right ventricle for pacing, sensing, cardioversion, and defibrillation when a cardiac implantable electronic device is indicated to treat patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias.

Functional description

The device is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter delivered, transvenous ventricular lead with an RV defibrillation coil electrode. The lead has a nonretractable helical electrode made of titanium nitride coated platinum alloy for active fixation in the endocardium by rotating the lead body in a clockwise direction. Upon exposure to body fluids, the steroid elutes from the lead tip.