Diagnostics company Angel Medical Systems has secured approval from the US Food and Drug Administration (FDA) for its second-generation AngelMed Guardian device.
The system is claimed to be the world’s first implantable cardiac detection monitor and patient-warning system for acute coronary syndrome (ACS) events such as silent heart attacks.
AngelMed said that the real-time cardiac monitoring device is implanted subcutaneously by a cardiologist during a low-risk, outpatient surgical procedures.
The system uses a patented algorithm to continuously record the heart’s electrical activity round the clock. It helps to monitor electrical changes, which could indicate an impending ACS event.
According to the company, the second-generation device is integrated with ease-of-use adaptations and an updated long-life battery to double the life of the implanted device.
The advanced device offer a more effective diagnosis of a life-threatening condition when compared to patient symptoms alone, said the company.
AngelMed CEO Brad Snow said: “The improved AngelMed Guardian device will have a meaningful effect on the current standard of patient cardiology care for ACS events. Our dedicated team and supporting physicians have worked tirelessly to bring this disruptive technology to market.
“As the first real-time detection device for high-risk heart attack patients, the AngelMed Guardian System provides critical data at the point of care, along with peace of mind for physicians and patients alike.”
In September, AngelMed announced the first implant of the next-generation AngelMed Guardian system was done on a former ALERTS study patient in the US.
The device implant was carried out as part of the ALERTS-Continued Access Study.
