Shrewsbury, NJ-based Angel Medical Systems has announced CE Mark approval of its AngelMed Guardian technology. The system, which is currently undergoing clinical trials in the US, was described by us back in 2009 as a “package [that] includes an implantable monitor, with a lead stretching into the heart, that watches for ST changes in the ECG electrical signal. This unit communicates via Bluetooth with a pager-like device worn by the patient that signals for when it predicts a possible MI onset.”
From the latest press release:
The AngelMed Guardian is commercially available in Brazil and is currently being tested in the United States in the ALERTS Phase II Clinical Study under an investigational device exemption (IDE) from the FDA.
Dr. C. Michael Gibson of Harvard Medical School, who is leading the ALERTS study says, “Over the past two decades, it has routinely taken patients 2-3 hours to arrive at the hospital with a heart attack. Our initial studies indicate that this device may reduce that time to approximately 20 minutes. When time is muscle, every minute counts and our hope is that survival will be improved.”
Company announcement: Angel Medical Systems Receives CE Mark Approval for the AngelMed Guardian, an Implantable Device Designed to Provide Early Warning of a Heart Attack…
Product page: The AngelMed Guardian® system…
Flashback: AngelMed Guardian System Aims to Predict Heart Attacks
