Device Dossier

Epsila EV MRI SureScan EV2401 - Lead, defibrillator, implantable

Device Dossier for Epsila EV MRI SureScan EV2401 - Lead, defibrillator, implantable (Lead, defibrillator, implantable, Class III, sponsor Medtronic).…

Intended purpose

The Medtronic Epsila EV Model EV2401 lead is a sterile, single-use only, magnetic resonance (MR) conditional, extravascular quadripolar lead with shaped passive fixation that is designed for sensing, cardioversion, defibrillation, and pacing therapies. It is placed in the anterior mediastinum and connected to an extravascular implantable cardioverter defibrillator (EV-ICD). The Aurora EV-ICD MRI SureScan system has application in the treatment of sudden cardiac death (SCD).

Functional description

The Medtronic Epsila EV Model EV2401 lead is an extravascular quadripolar lead with shaped passive fixation, designed for sensing, cardioversion, defibrillation, and pacing therapies. The lead has been tested for use in the magnetic resonance imaging (MRI) environment. All lead lengths for this lead model are MR Conditional

TGA Public Summary