Device Dossier

Plexa ProMRI S DX - Lead, defibrillator, implantable

Device Dossier for Plexa ProMRI S DX - Lead, defibrillator, implantable (Lead, defibrillator, implantable, Class III, sponsor Biotronik). ARTG record,…

Intended purpose

In combination with a compatible ICD, this lead is designed for the following: • Permanent sensing and pacing in the right ventricle • Permanent sensing in the right atrium • Delivery of defibrillation / cardioversion therapies

Functional description

The lead body consists of a coil made embedded in silicone. It has a RV shock coil and the tip is an extendable /retractable screw (distal pole), for fixating in the myocardium. Bipolar sensing in the atrium with 2 atrial ring electrodes, sensing and pacing in the ventricle, between the distal pole and ventricular ring electrode. The leads coating improves gliding properties. Steroid reduces inflammation and threshold increase after implantation. MR conditional.

TGA Public Summary