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…
- GMDN category: Lead, defibrillator, implantable
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)