FDA approves AngelMed Guardian System to detect acute coronary syndrome events.- Angel Medical Systems.

Angel Medical Systems, Inc. has received FDA premarket approval (PMA) for the �AngelMed Guardian System�. The AngelMed Guardian System is an implantable cardiac monitor with patient alerting capability and an additional external alarm device.

It is indicated for use in patients who have had prior Acute Coronary Syndrome (ACS) events including myocardial infarctions (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, characterized by sustained ST segment changes, and alerting the patient to seek medical attention for those events. The Guardian System is implanted like a pacemaker, typically in less than an hour under a local anesthetic.

This well-studied implantation technique demonstrated an adverse event rate that was also very similar to the rate seen for pacemaker implants. The types of adverse events seen were also similar to those seen with pacemaker implants.