Virginia Cardiovascular Associates and Angel Medical Systems announce ALERTS pivotal study for implantable cardiac monitor and alert system


Virginia Cardiovascular Associates announced participation in the ALERTS pivotal US trial for the AngelMed Guardian implantable cardiac monitor and alert system. The system is designed to reduce the time it takes patients to get to the emergency room during an impending heart attack.

The AngelMed Guardian system is designed to track significant changes in the heart’s electrical signal and then alert patients to seek medical attention. The objective of the ALERTS pivotal study is to provide an assessment of the safety and effectiveness of the AngelMed Guardian system.

Shawn Yazdani, Virginia Cardiovascular Associates, said “Virginia Cardiovascular Associates is very excited to offer this potentially lifesaving modality to the community and to our patients. By detecting a heart attack about to happen early, not only is there potential to save lives but we can also potentially limit the degree of muscle damage, which directly correlates with the long term morbidity of the patient. The AngelMed Guardian implantable cardiac monitor and alert system could help us achieve this objective.”

According to the American Heart Association, one of every five deaths in the USA is attributable to coronary heart disease. Further, 50% of heart-attack fatalities occur within one hour of symptom onset and occur before the patient even reaches the hospital.

“Experimental and clinical studies have shown that most of the damage to the heart occurs very soon after coronary occlusion,” said AngelMed’s chief operating officer Jonathan Harwood. “We have designed the device to warn patients of this and other cardiac events hours, perhaps days, before they occur.”

The AngelMed Guardian system is comprised of an internal implantable device about the size of a standard pacemaker with a lead into the heart, an external telemetry device, and a programmer that aids physicians in evaluating heart signals.

“When someone has a heart attack, it is typically the result of a blood clot closing one of the three major coronary arteries. When this happens, there is a shift in the ST segment of the heart signal caused by the electrical difference between the portion of the heart muscle fed by the closed artery and the rest of the heart that is still receiving oxygen,” adds AngelMed’s CEO, David Fischell, “The ALERTS trial is designed to test the Guardian’s ability to detect this electrical shift in a clinical setting and then provide an early warning to patients that could potentially save their lives.”