FDA Panel Gives Cardiac Ischemia Monitor Two Thumbs Down

— AngelMed Guardian device data failed to convince on safety or efficacy

by Nicole Lou, Staff Writer, �鶹��ý March 17, 2016

An FDA advisory committee on Wednesday voted unanimously (0-12) against a net benefit of the AngelMed Guardian System for patients at risk of recurrent acute coronary syndrome events.

The implantable device monitors for ST-segment changes on intracardiac electrocardiogram. When detected, the internal device (similar in size and placement to a pacemaker) vibrates to alert the patient while also setting off an external alert device. According to the sponsor's briefing document, "The Guardian System is designed to reduce the time from a coronary occlusion until presentation at a medical facility."

In the ALERTS study, AngelMed met its safety endpoint -- freedom from device-related complications at 6 months -- but failed to show efficacy in prevention of late hospital arrival (>2 hours), new Q-wave, and death. In addition, the study was terminated prematurely due to concerns of unreliable data -- a major protocol violation in the eyes of the FDA reviewers.

The advisory panel, chaired by , of University of Wisconsin School of Medicine & Public Health in Madison, voted 4-8 that the device is safe for patients and 0-12 that it is effective.

"Reviewing the data, it wasn't convincing that device is ready for prime time. It seems premature to approve this device," agreed , of Chicago's Rush University Medical Center, who was not part of the FDA advisory committee.

One key issue, he told �鶹��ý in a telephone interview, is that the AngelMed device is "quite invasive. It requires patients undergo a procedure like a pacemaker implantation."

"The cost would also be substantial," he added. So "before a device like this should be approved, it should show efficacy."

Nevertheless, there are many patients who would stand to benefit from a safe and effective device for early warning of coronary ischemia if it could be proven safe and effective, he suggested.

"The concept of the high-risk people getting this to be alerted faster is certainly compelling. The bottom line is this is fantastic idea with clinical potential, but the efficacy data have to be very clearly in favor of implanting this device," Schaer said.

The FDA is not obligated to follow the approval recommendations of its advisory committees but usually does.

Nicole Lou is a reporter for �鶹��ý, where she covers cardiology news and other developments in medicine.