Guardian System Designed to Address the Challenge of Patients Not Recognizing or Responding Quickly to Heart Attacks
(Shrewsbury, NJ – February 8, 2016) Angel Medical Systems Inc. has announced that the Circulatory System Devices Panel (CSDP) of the U.S. 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.
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 alerts 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," said Dr. David Holmes, Jr., co-Principal Investigator and Professor of Medicine at the Mayo Clinic "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."
The Advisory Committee will review data submitted in the PMA from the pivotal study of the Guardian System called ALERTS. This trial was a randomized, 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 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. "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." said Dr. C. Michael Gibson, Professor of Medicine, Harvard Medical School and ALERTS Study Principal Investigator.
"The upcoming Advisory Panel meeting represents important progress toward our goal of obtaining FDA approval of the Guardian System. We look forward to presenting the safety and efficacy data and the overall benefit-risk profile of the Guardian System to the Advisory Panel and will continue to work interactively with the FDA during the review period," stated Dr. David Fischell, CEO of Angel Medical Systems.
In conjunction with the scheduling of the CSDP 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.
About Angel Medical Systems
Angel Medical Systems, Inc. is a privately held medical device company developing implantable cardiac monitoring technologies for heart attack detection and alerting. For more information go to: http://www.angel-med.com/
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