FDA Advisory Committee to review AngelMed Guardian system for pre-market approval

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The Circulatory System Devices Panel (CSDP) of the US Food and Drug Administration (FDA) will review Angel Medical Systems’ premarket approval (PMA) application for the AngelMed Guardian system at a meeting on the 16 March 2016.

The AngelMed Guardian system is an implantable cardiac monitor, designed to detect rapid changes in the heart’s electrical signal caused by a coronary artery occlusion, the precursor to a heart attack. Once an occlusion is detected, the system is designed to alert patients to seek medical care by delivering a series of vibratory, auditory, and visual warnings.

“Reducing the time to treatment following a coronary occlusion is universally accepted by cardiologists as a means to reduce the harm associated with heart attacks,” says David Holmes, Jr, co-principal investigator and professor of Medicine at the Mayo Clinic. “Heart attack symptoms often go unrecognised, if they occur at all, leading to dangerous delays in treatment. The Guardian System could significantly benefit high-risk patients by providing them a clear signal to seek immediate medical attention if they experience a coronary occlusion.”

The Advisory Committee will review data submitted in the PMA from the pivotal study of the Guardian System called ALERTS. This trial was a randomised, prospective 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 6-month period to assess whether AngelMed Guardian system alerts reduced the composite incidence of death, new Q-wave myocardial infarction, or late presentation for thrombotic coronary occlusion events. “This study was designed to demonstrate the ability of the AngelMed Guardian system to alert patients to quickly seek medical attention for potential heart attacks.” says C Michael Gibson, professor of Medicine,
Harvard Medical School, Boston, USA and ALERTS Study Principal Investigator.

In conjunction with the scheduling of the CSDP meeting, AngelMed also received the final $10 million tranche of a milestone-based $40 million convertible note financing that had its initial closing in 2012.