EATONTOWN, N.J., July 27, 2021 /PRNewswire/ -- Angel Medical Systems, Inc., (dba AngelMed) a proactive diagnostics company focused on the advancement of long-term management of high-risk coronary disease, announced today the first commercial implantation and U.S. launch of its flagship product, The Guardian™ device. The procedure marks The Guardian's first use following its recent FDA approval. Indicated for acute coronary syndrome (ACS) events, including silent heart attacks, The Guardian System is the first implantable cardiac detection monitor and patient-warning system.
The outpatient procedure was successfully performed by cardiac electrophysiologist and cardiologist Dr. Andrew J. Kaplan of Cardiovascular Associates of Mesa in Mesa, Arizona. Dr. Kaplan is a pioneer of new cardiac technologies and has played a significant role in The Guardian's commercialization. He is a clinical trial investigator and serves on AngelMed's medical advisory board.
"The first commercial implant of The Guardian marks a pivotal advancement in cardiac care. The device detects impending ACS events, including silent heart attacks, and leads to earlier patient treatment," said Dr. Andrew Kaplan. "Given the device's clinical success, the cardiovascular community can feel confident in this new, first-in-kind technology. The Guardian fills a true unmet need in high-risk ACS patients."
The recently approved Guardian device is the first version of the product to be made commercially available. The updated version of the device is enhanced with ease-of-use adaptations and an updated, long life battery that could potentially double the life of the implanted device.
"We are elated to bring The Guardian System to market. The device's ability to provide high-risk heart attack patients with around the clock monitoring offers comfort to both at-risk patients, caregivers, and their healthcare providers said Brad Snow, AngelMed chief executive officer. "We look forward to continuing to have a substantial impact on the standard of cardiology care for years to come."
Every 40 seconds, someone in the U.S. suffers a myocardial infarction or heart attack.1 The most important risk factors for another cardiovascular event in post-heart attack patients are age, medical history, comorbidities, and the severity of their first ACS event.2 Despite proactive ongoing efforts over the last decade from the medical community to better educate the public on signs and symptoms of a heart attack, the time from symptom onset to arrival at a hospital remains static at eight hours.3
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About AngelMed Guardian System
The Guardian device is implanted subcutaneously by a cardiologist during a low-risk, outpatient surgical procedure. Using a patented algorithm, the AngelMed Guardian continuously records the heart's electrical activity, 24 hours a day, monitoring for electrical changes that can indicate an impending ACS event. The AngelMed Guardian device provides a more effective diagnosis of a life-threatening condition when compared to patient symptoms alone.4
About Angel Medical Systems, Inc.
Angel Medical Systems, Inc., is a proactive diagnostics company committed to advancing life-sustaining, personalized patient care, including the long-term management of high-risk coronary disease. Angel Medical Systems maintains a robust portfolio of U.S. patents relating to detecting cardiac events, including silent heart attacks.
1Centers for Disease Control and Prevention. (2012, August). NCHS data brief: Prevalence of Uncontrolled Risk Factors for Cardiovascular Disease: United States, 1999–2010 (No. 109). Retrieved from https://www.cdc.gov/nchs/data/databriefs/db103.pdf.
2 Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;130(25):2354-2394. doi: 10.1161/CIR.0000000000000133.
3 Holmes DR, Krucoff MW, Mullin C, et al. Implanted monitor alerting to reduce treatment delay in patients with acute coronary syndrome events. J Am Coll Cardiol. 2019;22:2047-2055. doi: 10.1016/j.jacc.2019.07.084.
4 Food and Drug Administration Website. Summary of Safety and Effectiveness Data. https://www.fda.gov/media/96475/download. Accessed May 6, 2021
SOURCE Angel Medical Systems