The FDA this week approved Angel Medical Systems AngelMed Guardian implantable cardiac monitor system after the device had previously been rejected unanimously by an FDA advisory panel in 2016.
The initial rejection came after the Tinton Falls, N.J.-based company presented partial data from its pivotal trial of the device in after having pulled the plug on it before completion, according to a Healio report from 2016.
The panel voted 4 to 8 that the system was safe, and unanimously that the device was ineffective and that the benefits did not outweigh the risk, according to Healio.
Angel Medical eventually won approval, however, after submitting a new retrospective analysis which the FDA. After reviewing the analysis, the agency stated that “the results of that analysis demonstrate a positive benefit-risk profile for the device,” according to an FDA filing.
The AngelMed system is an implantable cardiac monitor designed to alert the patients with an external alarm device, and is now indicated for use in patients who have had prior acute coronary syndrome events including myocardial infarctions or unstable angina, and remain at a 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. 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,” CEO Dr. David Fischell said in a prepared release.
The system is designed to be implanted in a procedure performed under local anesthetic. Angel Medical claimed that the implantation technique used with the device had an adverse event rate similar to pacemaker implants.
“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,” Alerts pivotal clinical study primary investigator Dr. C. Gibson of Harvard Medical School said in a prepared statement.
“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,” COO David Keenan said in a press release.