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FOR IMMEDIATE RELEASE
Data from the ALERTS Clinical Study for The AngelMed Guardian System®
Published in JACC and Presented as a Late-Breaking Trial at CRT 2019
Data Indicates The Guardian® May Be Beneficial in the
Confirmation of Symptomatic and the Detection of Asymptomatic
ACS Events Among High Risk ACS Patients
Washington D.C., March 4, 2019 – Data from the ALERTS Clinical Study for The AngelMed Guardian® System was published in the Journal of the American College of Cardiology (JACC). Those findings were presented as a late-breaking trial at the Cardiovascular Research Technologies (CRT) 2019 Conference this weekend at the Omni Shoreham Hotel in Washington,
D.C. by Harvard Professor, C. Michael Gibson, MD, the national Principal Investigator (PI) for the
study. The AngelMed Guardian® System is an implantable cardiac monitor and patient alerting system that received approval by the FDA in April 2018 for patients with prior acute coronary syndrome (ACS) events who remain at high risk for recurrent ACS events.
Authors of the JACC article, “Implantable Cardiac Alert System for Early Recognition of STSegment Elevation Myocardial Infarction,” stated that “symptoms remain a poor prompt for
acute coronary syndromes (ACS).” The report details that in the study of 907 high-risk ACS patients, The Guardian® reduced the rate of false positive presentations to the emergency room compared to symptoms alone in the control patient group and also detected ACS events in the absence of symptoms. Together, these findings indicate that The AngelMed Guardian® System may be beneficial in the confirmation of symptomatic and the detection of asymptomatic ACS events among high risk ACS subjects.
“As Dr. Gibson discussed in his presentation, The Guardian® has shown that it can get patients to the ER even if they do not have symptoms of ACS events, including silent heart attacks. This is a first-ever capability for any product and allows The Guardian® to fill an unmet medical need by providing more effective diagnosis of a life-threatening condition compared to relying on patient symptoms alone. We are profoundly grateful to the authors of the JACC article and CRT organizers for giving the data from the ALERTS Clinical Study exposure among our respected colleagues. We look forward to bringing the device to market later this year,” said Dr. David R. Fischell, the CEO of Angel Medical Systems, Inc.
About The AngelMed Guardian® System
The AngelMed Guardian® System received approval by the U.S. Food and Drug Administration
(FDA) in April 2018. It is an implantable cardiac monitor with patient alerting for patients who
have had prior Acute Coronary Syndromes (ACS), including myocardial infarctions (heart
attacks) or unstable angina and who remain at high risk for recurrent ACS events. The
Guardian® System is an adjunct to patient recognized symptoms by detecting potential ongoing
ACS events, characterized by sustained ST segment changes and alerting the patient to seek
medical attention for those events. 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.
About Angel Medical Systems, Inc.
Angel Medical Systems, Inc. was founded in 2001 by Drs. Robert, Tim and David Fischell, active
serial entrepreneurs and inventors of medical devices. In 1999, the company filed its first of
more than 50 issued US patents relating to detecting cardiac events and patient alerting, with
the Company’s first human implant occurring in 2005.
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