News | October 01, 2010

Early-Warning Coronary Occlusion System Receives CE Mark

October 1, 2010 – An early-warning system for detecting coronary occlusion has received the CE mark for commercial sale in Europe. The AngelMed Guardian System, by Angel Medical Systems, is designed to detect coronary occlusion from thrombotic events, such as plaque ruptures, and alert the patient, often before any symptoms occur.

The implantable device is about the size of a pacemaker and has vibrational warning. It connects to the heart using a standard pacemaker lead. External alerts are also provided by a pager-like system.

The AngelMed Guardian is currently being tested in the United States in the ALERTS Phase II Clinical Study.

"Over the past two decades, it has routinely taken patients two to three 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,” said C. Michael Gibson, M.D., Harvard Medical School and principal leader of the study. “When time is muscle, every minute counts and our hope is that survival will be improved."

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