Device Dossier

INVICTA Lead - Lead, defibrillator, implantable

Device Dossier for INVICTA Lead - Lead, defibrillator, implantable (Lead, defibrillator, implantable, Class III, sponsor Microport Crm). ARTG record,…

Intended purpose

INVICTA leads (1CR and 2CR) are right ventricular steroid-eluting defibrillation leads intended for the treatment of life-threatening ventricular arrhythmias when used in conjunction with an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy defibrillator (CRT-D). The leads transmit the electrical signal from the myocardium to the ICD/CRT-D, and deliver electrical impulses and/or shocks to the ventricle for pacing, antitachycardia pacing (ATP) and/or defibrillation. The device(s) are MR conditional in the 1.5T and 3T MR environments only.

Functional description

The INVICTA models 1CR and 2CR transvenous tachyarrhythmia leads are true bipolar, steroid eluting, active fixation leads. The leads are designed for implantation with the distal tip positioned in the right ventricle for pacing, sensing, cardioversion and defibrillation therapies. The steroid aims to minimize the inflammatory response and to reduce threshold elevation during the first weeks post-implantation.

TGA Public Summary