An FDA advisory committee has recommended against approving the premarket approval application for Angel Medical Systems’ Guardian implantable cardiac monitor.
During a meeting last week, the Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 8 to 4 that the device was not safe and 12 to 0 that the device was neither effective nor do the benefits outweigh its risks.
The AngelMed Guardian system is designed to detect rapid changes in the heart’s electrical signal caused by a coronary artery occlusion, the precursor to a heart attack.
If an occlusion is detected, the system alerts patients to seek medical care by delivering a series of vibratory, auditory and visual warnings.
The panel reviewed data from a study of 907 high-risk subjects who had experienced a previous heart attack or acute coronary syndrome event. All subjects were implanted with the AngelMed Guardian system and assigned to have the alerting feature of the device either turned on or off for a six-month period.
The trial’s primary safety endpoint was met – demonstrating a greater than 90 percent freedom from system-related complications based on six months of data.
But, the trial failed to meet the primary efficacy outcome by reducing the rate of a composite of:
In testimony at the meeting, Michael Carome, director of Public Citizen’s Health Research Group, urged the panel to recommend that the FDA not approve the device.
Not only did the trial fail to show that the device was effective, but the conduct of the study was marred by serious protocol violations that undermined its integrity and validity, he said.
The FDA said the quality of the ECG data and the inconsistency of the Q wave results caused the sponsor to terminate the study earlier than the protocol required — a move that potentially caused bias.
The device also poses serious risks that are unacceptable given the lack of evidence of effectiveness, said Carome.
“The only reasonable course of action for the FDA is to reject the Guardian System. Allowing this device on the market would be a reckless decision,” he said.
Following the meeting, Andrew Taylor, president and CFO of the company, expressed disappointment, but that the devicemaker believed the benefits of the device outweigh the risks.
The recommendation against approving the AngelMed Guardian System came a day after the panel voted to support Abbott’s drug-eluting coronary stent Absorb — a device that, if approved, would become the first fully bioresorbable vascular scaffold in the U.S. (see related story). — Jonathon Shacat