AngelMed Announces First Implant of Next-Generation AngelMed Guardian® in the U.S.


EATONTOWN, N.J., Sept. 30, 2020 /PRNewswire/ -- AngelMed is pleased to announce that on Tuesday, September 29th, a former ALERTS Study patient in the United States received the first implant of the next-generation AngelMed Guardian® System as part of the ALERTS-Continued Access Study. The AngelMed Guardian is the only implantable, patient alerting system designed to warn patients to seek medical attention for acute coronary syndromes (ACS), including heart attacks.

The implant of the newly refined AngelMed Guardian was performed by Kelly Tucker, M.D., Director, Electrophysiology, Orange County Heart Institute and Research Center at Pavilion Surgery Center in Orange, CA. 

"The AngelMed Guardian represents a real game changer in the management of coronary artery disease. This is the first ever surveillance tool for patients with a prior coronary event and has the potential to save countless lives and bring peace of mind to thousands of families. It is a great honor to be involved in this amazing technology," said Kelly Tucker, M.D.

According to the American Heart Association, the estimated annual incidence of heart attack in the US was 605,000 new and 200,000 recurrent attacks. Studies have shown that at least 25% of MIs are unrecognized or silent.

The AngelMed Guardian system is designed to track significant changes in the heart's electrical signal and then alert patients to seek medical attention – this includes detection of silent heart attacks. The objective of the ALERTS-Continued Access Study is to provide former ALERTS patients access to this life-changing device.

AngelMed CEO Gordie Nye commented, "We are thankful to the FDA for allowing us to perform this study so that our previous ALERTS patients may get the AngelMed Guardian back. These pioneers still to this day remain pivotal to our success and we as a company are excited for the road ahead as we move closer to commercialization."

Pavilion Surgery Center and Orange County Heart Institute and Research Center is the first medical facility to participate in the AngelMed Guardian ALERTS-Continued Access study.

Dr. David Fischell, Founder and Chairman of AngelMed added, "Tremendous thanks to Dr. Tucker and the entire AngelMed team that made today's implant possible. However, for me, it has always been first and foremost about our patients. We are specially pleased to be able to begin re-implanting our ALERTS patients whose willingness to participate in our clinical trial was critical to obtaining FDA approval for the Guardian System. This is the start of a brighter future for ACS and heart attack survivors in the United States."

About Angel Medical Systems, Inc.
Angel Medical Systems, Inc. was founded by Drs. Robert, Tim and David Fischell to advance life-sustaining patient care and the long-term management of High-Risk Coronary Artery Disease. The AngelMed Guardian System received approval by the U.S. Food and Drug Administration (FDA) in April 2018. The AngelMed Guardian® 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.

Forward Looking Statements
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward- looking statements. A number of risks and uncertainties, such as risks related to product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the Company's products to patients, market and physician acceptance of the Company's products, intellectual property protection and competitive product offerings, could cause actual events to differ from the expectations indicated in these forward-looking statements. You are cautioned not to put any undue reliance on any forward-looking statement. This press release is neither an offer to sell nor a solicitation of an offer to purchase any particular securities. Any such offer or solicitation will be made only pursuant to definitive legal agreements prepared specifically for such purpose. An investment in the Company's securities entails significant risks and is suitable only for sophisticated investors who can afford a loss of their entire investment; no assurance can be given that investment objectives will be achieved. In considering the performance information contained herein, you should bear in mind that past performance is not necessarily indicative of future results; there can be no assurance that the Company will achieve comparable results or that any projected returns will be met. The Company does not assume any obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events, or otherwise.

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