Device Dossier

XFINE Endorcardial Pacing Lead - Lead, pacemaker, implantable, endocardial

Device Dossier for XFINE Endorcardial Pacing Lead - Lead, pacemaker, implantable, endocardial (Lead, pacemaker, implantable, endocardial, Class III,…

Intended purpose

The XFINE lead is a right atrial or ventricular endocardial steroid-eluting passive fixation pacing lead intended for the treatment of brady arrhythmias. The XFINE lead, when used in combination with a compatible pacemaker or defibrillator, transmits the electrical signal from the atrial or ventricular myocardium to the device and delivers electrical impulses to the atrium or ventricle for pacing. Passive straight leads (TX models) can be used in the ventricle. Passive J-shape leads (JX models) can be used in the atrium. XFINE leads are suitable for MRI (allowing patients to safely undergo an MRI examination) with a MicroPort MR Conditional pulse generator device.

Functional description

The XFINE lead is a bipolar, endocardial, steroid-eluting, straight (TX) or J-shape (JX), passive fixation lead for permanent pacing and sensing of either the atrium or ventricle. The lead is designed to be used with implantable cardiac pacemakers and defibrillators. In this steroid-eluting lead, a silicone elastomer collar containing 310 μg of Dexamethasone Sodium Phosphate (DSP) is located just behind the electrode tip.

TGA Public Summary