MELBOURNE, Australia, – Hydrix Limited has announced that it has secured the exclusive rights to distribute the AngelMed Guardian® System (Guardian) in Australia and a number of significant Asian countries including Singapore and Japan.
- The Guardian 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.
- The faster a heart attack is diagnosed and treated, the greater the chance of a full recovery by the patient. The Guardian identifies ACS symptoms with more certainty than the patient alone and alerts them to immediately seek medical help.
The Guardian is intended for use in patients who have previously suffered an ACS event and who remain at high risk for recurrent events. The implanted device continuously monitors a patient’s heart signal 24/7 and uses artificial intelligence (AI) to detect an impending heart attack
When the Guardian detects suspect heart activity, it immediately alerts the patient to seek medical attention with the implant vibrating within the chest and a separate wireless pager-like device alerting 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:
- Fifty percent of all heart attacks have either no symptoms (silent) or have atypical symptoms that are often ignored or not recognized.
- Eight percent 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 Guardian device reduced this to less than two hours.
During AngelMed’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.
In speaking about the agreement, Hydrix Chairman, Gavin Coote said “Coronary heart disease is the leading cause of death globally. The AngelMed Guardian will help save lives and lower overall healthcare costs. We are pleased and proud to be able to collaborate with AngelMed founder and chief executive officer (CEO) Dr David Fischell. He and his family were early developers of pacemaker and coronary stent technologies which later went on to become ‘gold standards’ in cardiac care, and we equally expect the Guardian to become a game changer.”
Peter Lewis, chief executive officer (CEO) of Hydrix said: “The technology developed by the team at AngelMed is world-class. The Guardian is part of Hydrix’s commitment to developing products and technologies which help improve the quality of life for patients around the world. We look forward to a long relationship with AngelMed as we help make the Guardian System become the new standard of cardiac patient care in the Asia Pacific.”
AngelMed chief executive officer (CEO), Dr David Fischell said: “We are delighted to appoint Hydrix to be our exclusive distributor of the Guardian System in Asia Pacific. Their regulatory and product engineering track record working with innovative global medical device companies and market knowledge makes them an excellent strategic partner for AngelMed”.
Subject to regulatory approvals, the AngelMed Guardian System is expected to launch in Australia within the 2021 financial year.