Device Dossier

Pamira S - Lead, defibrillator, implantable

Device Dossier for Pamira S - Lead, defibrillator, implantable (Lead, defibrillator, implantable, Class III, sponsor Biotronik). ARTG record, intended…

Intended purpose

The leads transmit electrical signals to and from the heart muscle. The leads are implanted in the right ventricle of the heart via a transvenous approach. The implantation of leads is intended to enable a compatible ICD device to: • sense electrical activity of the heart to monitor • pace the right ventricle, including antitachycardia pacing (ATP) • deliver therapeutic shocks In order to avoid increasing pacing thresholds, a steroid eluting collar is located at the lead tip, reducing myocardial inflammation after the implantation and subsequent fibrosis.

Functional description

Polyurethane tube for high durability and external abrasion protection • Fixation: extendable/retractable fixation screw, electrically active • Shock coil: 1 x RV • Bipolar sensing and pacing in the ventricle • Insulation surface coating improves the lead body's gliding properties • Steroid collar on the lead tip reduces inflammatory processes and undesired threshold increases after implantation • Connections: 1 x DF4 (tripolar)

TGA Public Summary