A heart attack can feel like literally anything. A sore arm, jaw pain, nausea… The list goes on.
Difficulty in recognising a heart attack due to atypical symptoms increases for women, elderly and diabetics. The wide scope of symptoms can often result in costly emergency room visits and tests just to discover simple indigestion is the cause.
Distributed by medtech engineering company Hydrix (ASX: HYD), the AngelMed Guardian System is the world’s first and only implantable cardiac monitor and patient alerting system. The device recognises signs of acute coronary syndrome (ACS) events and alerts the patient to seek medical care.
Implanted like a regular pacemaker, the device has the ability to monitor the heart’s electrical signals 24 hours a day, 7 days a week. When the Guardian detects a potential ACS it will vibrate and communicate with a small external device that beeps and flashes. This alerts the patient to the need to contact their doctor or call an ambulance.
Doctors can wirelessly retrieve information collected by the Guardian to inform the best treatment option.
The device has been approved by the US FDA for commercial release. Hydrix has today announced that they have completed submission to the Australian Therapeutic Goods Administration (TGA) for the device’s inclusion on the Australian Register of Therapeutic Goods. The application cites US FDA approval and includes additional information specific to Australian requirements.
Hydrix anticipates approval from the TGA in the first half of the 2022 calendar year.
Paul Kelly, General Manager said: “With each milestone achievement, we move one step closer towards commercialisation of the world’s only implantable heart attack alert system.”
The Company is also working with the Medical Services Advisory Committee to gain approval for the procedure to be included in the Medical Benefits Schedule, to provide a fee for the implanting physician, and approval from the Prostheses List Advisory Committee to enable reimbursement of the device under private health policies.
Hydrix has successfully designed over 200 products and solutions in medtech, mining and communications. Their three pronged business model allows them to address such varied markets. Hydrix Services designs and engineers client products, Hydrix Ventures generates equity returns through investments in high potential companies and Hydrix Medical brings med tech innovations to market.
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