Angel Medical's coronary occlusion warning system nets CE mark
Angel Medical Systems has received a CE mark for its AngelMed Guardian System, an implantable warning system used to detect coronary occlusions from thrombotic events such as plaque ruptures, before symptom onset.

According to the Shrewsbury, N.J.-based company, the device uses a vibrational alerting system and connects to a patient’s heart using a standard pacemaker lead.

The AngelMed device also is approved for marketing in Brazil and is being evaluated in the U.S. in the ALERTS Phase II clinical trial under an investigational device exemption from FDA.

The ALERTS trial will assess the safety of the device and its potential to reduce time to treatment, heart muscle damage and improve survival of cardiac events.

"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 the study’s principal investigator, C. Michael Gibson, MD, of the Harvard Medical School in Boston.