There are a number of ILR/ICM devices e.g. Medtronic Reveal and Linq devices. All MRI safety conditions can typically be satisfied. Except the AngelMed Guardian which is a different type of internal monitor that it is MR Unsafe (see below). Thus, we recommend you proceed as follows:
Establish using the MRI checklist if the patient has an ILR/ICM, and determine that the ILR/ICM is not the AngelMed Guardian, see below for further information.
The following assumes you are using a 1.5T or 3T closed bore MRI system for hydrogen proton MRI (i.e. the typical clinical MR imaging mode).
Do not use local transmit coils to image the chest, trunk, or shoulder region. That is, the body coil (inside the magnet bore covers) must be used for RF transmission of these areas with a receive only coil being placed over these particular areas of interest.
Scan the patient in Normal operating mode. There is no post-insertion waiting required, see risks assessments:
GenericRiskAssessmentForm_MRI_scanning_ILR_time
GenericRiskAssessmentForm_MRI_scanning_3T
GnericRiskAssessmentForm_MRI_scanning_ILR_under6weeks
Instruct the patient to inform the device specialist or doctor looking after their device and cardiac care of the date and time of the MRI scan at their next appointment. If no appointments are scheduled, there is no need to contact these health professionals.
How to make sure the ILR/ICM is not the AngelMed Guardian?
What is the AngelMed Guardian?
The AngelMed Guardian Implantable Medical Device (IMD) is an implantable programmable device that monitors the patient’s electrogram, vibrates to warn the patient of alarms and alerts, and stores electrogram signals and other data.
The AngelMed Guardian® System is available by prescription or order of a physician only in the USA as per website. The AngelMed Guardian has never being implanted in the UK, it is currently being implanted in the USA and some Asia-Pacific countries. As part of various trials, it was introduced and implanted in Brazil, details below.
How to identify this device in a patient?
This device is different shape than an ILR/ICM i.e. loop recorder. The AngelMed system has two components: an implantable device very similar to a single chamber pacemaker, and an external device that the patient carries on their person.
1.Has the patient have an External pager-like device, called EXD? Patient should have with them all the time.
Height: 2.8 in (70 mm)
Width: 2.2 in (55 mm)
Depth: 0.6 in (16 mm)
2. If chest x-ray available the AngelMed Guardian device has a radiopaque identifier AMSG3
AngelMed states “Do not have an MRI. An MRI creates a very powerful magnetic field that can damage your IMD and injure the tissue near your implanted lead”.
Where the device has been implanted, i.e. Trials?
Proof of Concept study (n=17) USA, Early 2000’s
First in-man Experience (n=76) USA and Brazil
A First-in-Man Study in Brazil (CARDIOSAVER) (n=20) Brazil and USA 2005
A US IDE Safety Study (DETECT) Phase I clinical feasibility study (USA) n=37, 2006
A Prospective Randomised Pivotal IDE Study (ALERTS), This is an international phase II, randomized,prospective. (n=907), 2014-2017.
Contact with company (13/07/2022), they do not implant (and have never implanted) the device in the UK. It is currently being implanted in the USA and some Asia-Pacific countries.