Device Dossier

Optisure Defibrillation Lead Model LDA210 - Lead, defibrillator, implantable

Device Dossier for Optisure Defibrillation Lead Model LDA210 - Lead, defibrillator, implantable (Lead, defibrillator, implantable, Class III, sponsor…

Intended purpose

For use with a compatible pulse generator to provide long‑term cardiac sensing, pacing, and delivery of cardioversion/defibrillation therapy to treat life‑threatening ventricular arrhythmias in the right ventricle.

Functional description

The lead is a true bipolar, steroid‑eluting, active fixation lead with one defibrillation shock coil and is designed for long‑term attachment to an ICD or a CRT‑D. The lead is designed for implantation with the distal tip positioned in the right ventricle and provide rate‑sensing, pacing, and delivery of cardioversion/defibrillation shocks. The lead is MR conditional.

TGA Public Summary