TINTON FALLS, N.J. – Angel Medical Systems has received approval from the U.S. Food and Drug Administration for an implantable cardiac monitor that could detect oncoming heart attacks before they happen.
The AngelMed Guardian System has patient alerting capability and an external alarm and is designed for patients who have had prior acute coronary syndrome, including heart attacks, unstable angina and those at high risk for recurrent ACS events.
“The Guardian device fills an unmet medical need by providing more effective diagnosis of a life-threatening condition when
compared to patient symptoms alone,” said Dr. David Fischell, CEO of Angel Medical Systems, in a statement. “The Guardian provides this adjunctive benefit without increasing the rate
of false positives and may in fact reduce that rate.”
The Guardian System, which is implanted like a pacemaker, was successfully tested in the ALERTS clinical study, which ran from 2009-2015 at 100 health centers across the U.S. with 910 patients implanted.
“Getting FDA approval is a major accomplishment in the 15-year history of Angel Medical Systems and represents the
combined efforts and significant contributions from our
employees, advisors, implanting doctors and, of course, the patients in our clinical studies,” said David Keenan, COO of Angel Medical Systems, in a statement.