Device Dossier
Plexa ProMRI DF-1 S - Lead, defibrillator, implantable
Device Dossier for Plexa ProMRI DF-1 S - Lead, defibrillator, implantable (Lead, defibrillator, implantable, Class III, sponsor Biotronik). ARTG record,…
- GMDN category: Lead, defibrillator, implantable
Intended purpose
Plexa ICD 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 Plexa ICD 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
• 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 increases in threshold after implantation • Connections: – 1 x DF-1 – 1 x IS-1 (bipolar)