Angel Medical Systems, Inc. of Tinton Falls announced that they have received FDA pre-market approval on a medical device that detects heart attacks before patients experience symptoms.
The AngelMed Guardian System is an implantable heart monitor with internal and external alerting capabilities to urge at-risk patients with pre-existing cardiac conditions to seek medical attention. The company said the device is the first of its kind.
“The Guardian device fills an unmet medical need by providing more effective diagnosis of a life-threatening condition when compared to patient symptoms alone. The Guardian provides this adjunctive benefit without increasing the rate of false positives and may in fact reduce that rate. A very important capability of the Guardian is that in the absence of symptoms, it may identify ACS events, including heart attacks, and prompt the patient to seek medical attention.” said Angel Medical System’s Chief Executive Officer, Dr. David R. Fischell.
Approval of the ‘AngelMed Guardian System’ by the U.S. FDA was based on preclinical and clinical data, including data derived from the ALERTS Clinical Study that began in 2009. One hundred centers across the U.S. participated in the ALERTS Clinical Study, with 910 patients implanted. The ALERTS Clinical Study concluded in 2015 after accumulating 3,450 implant years of follow-up data.
Angel Medical Systems Inc was founded in 2001 by the father and sons team of Drs. Robert, Tim and David Fischell.
