Healthcare Equipment and Supplies
Company Overview of Angel Medical Systems, Inc.
Angel Medical Systems, Inc., a medical device company, develops and manufactures continuous intracardiac ischemia monitoring and alerting devices for patients and their families in Brazil. It offers AngelMed Guardian system, an implantable cardiac device designed to detect rapid ST segment changes that may signify major cardiac events, such as coronary artery occlusions caused by life-threatening vulnerable plaque ruptures. The company’s AngelMed Guardian system includes an implantable device (IMD), which detects, analyzes, and records crucial heart signal data, as well as vibrates to alert patients of cardiac events; an external device (EXD) that provides additional auditory and visual aler...
788 Shrewsbury Avenue
Tinton Falls, NJ 07724
Founded in 2001
Key Executives for Angel Medical Systems, Inc.
Vice President of Research & Development
Vice President of Clinical & Regulatory Affairs
Compensation as of Fiscal Year 2017.
Angel Medical Systems, Inc. Key Developments
Angel Medical Systems Announces FDA Advisory Committee Meeting for Review of the AngelMed Guardian System
Feb 8 16
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 application for the AngelMed Guardian System at a meeting on 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. 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. 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.
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