Device Dossier

Assert-IQ EL+ Insertable Cardiac Monitor Model DM5500 - Implantable cardiac monitor

Device Dossier for Assert-IQ EL+ Insertable Cardiac Monitor Model DM5500 - Implantable cardiac monitor (Implantable cardiac monitor, Class III, sponsor…

Intended purpose

The Assert-IQ Insertable Cardiac Monitor (ICM) is intended to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review.

Functional description

The Assert-IQ ICM is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). The ICM is implanted using an incision and insertion tool that come packaged with the ICM. The device is MR conditional.

TGA Public Summary