FDA approves Angel Medical implantable cardiac monitor
Closely-held Angel Medical Systems has received FDA premarket approval for the AngelMed Guardian System, an implantable cardiac monitor with patient alerting capability and an additional external alarm device.
The system is indicated for use in patients who have had prior acute coronary syndrome (ACS) events, including myocardial infarctions, or heart attacks, or unstable angina and who remain at high risk for recurrent ACS events.
The Guardian System is an adjunct to patient recognized symptoms by detecting potential ongoing ACS events and alerting the patient to seek medical attention for those events. The system is implanted like a pacemaker, typically in less than an hour under a local anesthetic.
“A very important capability of the Guardian is that in the absence of symptoms, it may identify ACS events, including heart attacks, and prompt the patient to seek medical attention," CEO, Dr. David R. Fischell, said in a statement.
Dr. Michael Gibson of Harvard Medical School, who was national principal investigator for the company’s ALERTS pivotal study, said patients who have had a recent acute coronary syndrome often remain at high risk of a recurrent event.
“The AngelMed Guardian System has shown it can identify true heart problems better than patients' symptoms alone as well as in those patients who have no symptoms," he added.