Hydrix Limited (ASX:HYD) is the distributor of the AngelMed Guardian® in Australia and a number of significant Asian countries including Singapore and Japan.
The AngelMed Guardian is an implanted device that monitors a patient’s heart signal 24/7 using artificial intelligence (AI) to detect an impending heart attack. What makes the AngelMed Guardian unique is that it is:
The world’s first FDA-approved, implanted cardiac monitoring device that can alert patients of an impending Acute Coronary Syndrome (ACS) event, which includes heart attacks and unstable angina.
A novel technology that identifies ACS symptoms with more certainty than the patient alone and alerts them to immediately seek medical help. The faster a heart attack is diagnosed and treated, the greater the chance of a full recovery by the patient.
The AngelMed Guardian is intended for use in patients who have previously suffered an ACS event and who remain at high risk for recurrent events.
The AngelMed Guardian’s operation is based on the well understood and documented relationship between ST-segment changes and ischaemia. The AngelMed Guardian continuously monitors the patient’s heart signal for ST-segment changes and provides notification using three different types of alerting when an abnormal change occurs. When the Guardian detects suspect heart activity, it immediately alerts the patient to seek medical attention with the implant vibrating within the chest. The separate wireless pager-like device also alerts with sound and flashing LEDs.
The Guardian reduces the uncertainty of self-diagnosis. Currently, only patient recognized symptoms prompt patients to seek medical attention, but self-diagnosis of a potential heart attack is problematic given:
50% of all heart attacks have either no symptoms (silent) or have atypical symptoms that are often ignored or not recognized.
80% of the patients who present with chest pain are not having an ACS event (false positives) placing unnecessary burden on the hospital system.
Even when symptoms are recognized, a recent US study reported that the median time from symptom onset to arrival at a medical facility for heart attacks could be 12 hours or more. The same study found that the AngelMed Guardian reduced this to less than 2 hours.
During the AngelMed Guardian’s US clinical trials, approximately 900 patients had the device implanted with outcomes indicating lower morbidity rates, improved patient quality of life, reduction in heart damage and reduced length of hospital stay lowering patient healthcare costs.
The device is implanted in the same manner as a single lead pacemaker, a long-established and common procedure typically undertaken under local anaesthetic.
Accessing the AngelMed Guardian technology
The Guardian is not approved for sale in Australia. It will initially be made available to select patients via the TGA Special Access Scheme with an expected timing of late 2020/early 2021. At this stage, we are hopeful of having TGA approval to broadly distribute the device in late 2021.
In Singapore, subject to lifting of COVID-19 restrictions, we are ready to proceed with implants under a GN-26 Special Access Route (SAR).
For further information and updates on the AngelMed Guardian, please connect with us via the contact form below