Next month, an FDA advisory committee will consider Angel Medical Systems’ PMA application for its implantable cardiac monitor that notifies patients about changes that could signal an oncoming heart attack.
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 company says.
At the meeting, scheduled for March 16, the Circulatory System Devices Panel will review 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 to assess whether the system alerts reduced the composite incidence of death, new Q-wave myocardial infarction or late presentation for thrombotic coronary occlusion events, Angel Medical says.
The company declined to release information to IDDM regarding the study’s results and data prior to the advisory committee meeting.
The scheduling of the meeting triggered additional funding for Angel Medical, with the company receiving the final $10 million of a milestone-based $40 million convertible note financing that had its initial closing in 2012. — Jonathon Shacat