Angel Medical Systems Completes First Commercial Implant of the Guardian
ASX ANNOUNCEMENT 2/08/2021
Angel Medical Systems Completes its First USA Commercial Guardian Implant
Hydrix Limited (ASX: HYD, ‘Hydrix’ or the ‘Company’) today advises that Angel Medical systems has completed its first commercial implantation in the USA of the Guardian device (Guardian).
The outpatient procedure was successfully performed last week by cardiac electrophysiologist and cardiologist Dr. Andrew J. Kaplan of Cardiovascular Associates of Mesa, Arizona. Dr. Kaplan is a pioneer of new cardiac technologies and has played a significant role in The Guardian's commercialisation.
The procedure marks The Guardian's first use following recent FDA approval. Indicated for acute coronary syndrome (ACS) events, including silent heart attacks, the Guardian System is the first implantable cardiac detection monitor and patient-warning system.
In commenting on the successful implant, Dr Kaplan said:
"The first commercial implant of The Guardian marks a pivotal advancement in cardiac care. The device detects impending ACS events, including silent heart attacks, and leads to earlier patient treatment. Given the device's clinical success, the cardiovascular community can feel confident in this new, first-in-kind technology. The Guardian fills a true unmet need in high-risk ACS patients."
Hydrix recently announced it had completed its application to the Australian Therapeutic Goods Administration (TGA) for the Guardian System’s inclusion on the Australian Register of Therapeutic Goods (ARTG). Subject to the approvals process, Hydrix anticipates approval to be forthcoming in the first half of calendar year 2022. Once the device is included on the ARTG, Hydrix is able to market and sell the system commercially in Australia.
Paul Kelly, General Manager Hydrix Medical commented:
“Today’s announcement about the first USA commercial Guardian implant is yet another milestone achievement for the technology. It reinforces our confidence in achieving our goals as we progress towards commercialisation of the world’s only implantable heart attack alert system.”
Hydrix Limited (ASX: HYD) is a powerful product innovation company. Hydrix purpose is to enhance the health, safety, and wellbeing of one Billion lives. The company leverages its powerful product innovation capability across multiple growth platforms: Hydrix Services design and engineer client products which transform industries; Hydrix Ventures generate equity returns through investing in high potential companies; and Hydrix Medical bring innovative medical technologies to market.
The world's first and only (FDA approved) implantable cardiac monitor with ACS detection technology