Angel Medical Systems, Inc. has received FDA 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 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 recognised symptoms by detecting potential ongoing ACS events, characterised 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.
“The Guardian device fills an unmet medical need by providing more effective diagnosis of a life-threatening condition when compared to patient symptoms alone. The Guardian provides this adjunctive benefit without increasing the rate of false positives and may in fact reduce that rate. 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." said Angel Medical System’s Chief Executive Officer, Dr. David R. Fischell.
The national principal investigator for the ALERTS pivotal clinical study, Dr. C. Michael Gibson of Harvard Medical School, stated: "Patients who have had a recent acute coronary syndrome often remain at a 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."
"Getting FDA PMA approval is a major accomplishment in the 15 year history of Angel Medical Systems and represents combined efforts and significant contributions from our employees, advisors, implanting doctors and, of course, the patients in our clinical studies, who believed in us. Helping those patients was always foremost in our minds and hearts." said Angel Medical System’s Chief Operating Officer, David Keenan.