FDA Advisory Panel to Review Angel Medical's Implantable Device to Detect Heart Attack

February 8, 2016—Angel Medical Systems Inc. has announced that the Circulatory System Devices Panel of the US Food and Drug Administration will review the company's premarket approval (PMA) application for the AngelMed Guardian system at a meeting on Wednesday, March 16, 2016. In conjunction with the scheduling of the meeting, Angel Medical also received the final $10 million tranche of a milestone-based $40 million convertible note financing that had its initial closing in 2012.

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. When an occlusion is detected, the system alerts patients to seek medical care by delivering a series of vibratory, auditory, and visual warnings.

The advisory committee will review data submitted in the PMA from the ALERTS pivotal study of the Guardian system. This trial was a randomized, prospective study of 907 high-risk patients who had experienced a previous heart attack or acute coronary syndrome event. All patients were implanted with the 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 Guardian system alerts reduced the composite incidence of death, new Q-wave myocardial infarction, or late presentation for thrombotic coronary occlusion events. 

In the company’s announcement, C. Michael Gibson, MD, who is the ALERTS study's Principal Investigator, commented, “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.” Dr. Gibson is Professor of Medicine at Harvard Medical School in Boston, Massachusetts.

ALERTS Coprincipal Investigator David Holmes Jr, MD, added, “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. Heart attack symptoms often go unrecognized, 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.” Dr. Holmes is Professor of Medicine at the Mayo Clinic in Rochester, Minnesota.