The FDA has approved (PDF) Angel Medical Systems’ implantable cardiac monitor two years after a panel of experts unanimously rejected the device. Agency officials signed off on the device after Angel carried out additional clinical analysis of the troubled trial that got short shrift from its expert panel in 2016.
Angel had a rough time when it went before the FDA advisory panel armed with data from the single pivotal trial. The trial enrolled around 900 patients, but Angel pulled the plug early when an interim review revealed its adaptive model was unreliable. That left Angel with a flawed data set. And, while the experts expressed enthusiasm for the idea of a device that alerts patients to cardiac events, they were critical of the data.
“We have a trial that was terminated for design imperfections and incomplete or unreliable data and data quality issues,” panelist Scott Evans, Ph.D., said in 2016. “And we're struggling to connect the dots on how this same trial has the integrity to serve as the basis for regulatory approval.”
That could have marked the end of the road for the implant, but the FDA asked Angel to create a new clinical analysis plan. The result was a retrospective study of emergency department visits by patients who met certain criteria. This analysis included data gathered outside of the randomization period that weren’t reviewed by the expert panel. In light of that analysis, the FDA has ruled (PDF) that the device has a positive risk-benefit profile, the opposite conclusion to that reached by the panelists.
In signing off on the device, the FDA has tweaked the indication and tasked Angel with running a 500-patient prospective postapproval study to show the diagnostic accuracy of the device. While that is going on, Angel is free to start selling a product it sees helping acute coronary syndrome (ACS) patients who are at risk of recurrence.
“The Guardian device fills an unmet medical need by providing more effective diagnosis of a life-threatening condition when compared to patient symptoms alone,” Angel CEO David Fischell, Ph.D., said in a statement (PDF). “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.”