News | Cardiac Diagnostics | July 01, 2021

FDA Approves AngelMed Enhanced Real-Time Cardiac Monitor for Acute Coronary Syndrome (ACS) Events

AngelMed Guardian System prompts high-risk ACS patients to seek medical care

The FDA has cleared Angel Medical Systems' second-generation AngelMed Guardian device. The implantable cardiac device detects and warns patients if they are having an acute coronary syndrome (ACS) event, including silent heart attacks. The new, second-generation device is enhanced with ease-of-use adaptations and an updated, long life battery that could potentially double the life of the implanted device

The FDA has cleared Angel Medical Systems' second-generation AngelMed Guardian device. The implantable cardiac device detects and warns patients if they are having an acute coronary syndrome (ACS) event, including silent heart attacks. The new, second-generation device is enhanced with ease-of-use adaptations and an updated, long life battery that could potentially double the life of the implanted device

July 1, 2021 — The U.S. Food and Drug Administration (FDA) has cleared the Angel Medical Systems Inc. second-generation AngelMed Guardian device. It is the world's first implantable cardiac detection monitor and patient-warning system for acute coronary syndrome (ACS) events, including silent heart attacks. The new, second-generation device is enhanced with ease-of-use adaptations and an updated, long life battery that could potentially double the life of the implanted device.

The AngelMed 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.[1]

"Patients who have had a prior ACS event often remain at high-risk of a recurrent event. Even those patients who are on alert for another potential cardiac event may delay seeking treatment," said Michael Gibson M.D., Boston Clinical Research Institute. "The AngelMed Guardian System has demonstrated the ability to identify the earliest signs of an ACS event, including heart attacks, more effectively than patients' symptoms alone, and in patients who do not experience symptoms at all."

"The improved AngelMed Guardian device will have a meaningful effect on the current standard of patient cardiology care for ACS events. Our dedicated team and supporting physicians have worked tirelessly to bring this disruptive technology to market," said AngelMed Chief Executive Officer Brad Snow. "As the first real-time detection device for high-risk heart attack patients, the AngelMed Guardian System provides critical data at the point of care, along with peace of mind for physicians and patients alike."

"Our key learnings based on hundreds of thousands of hours of clinical monitoring data for many ambulatory patients with cardiovascular disease provides a technology platform for future offerings. Our patient-centric approach will drive our research and development," said Dave Keenan, AngelMed chief operating officer.

Every 40 seconds, someone in the U.S. suffers a myocardial infarction or heart attack.2 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.[3] 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.[4]

For more information: www.angel-med.com

References:

1. U.S. Food and Drug Administration Website. Summary of Safety and Effectiveness Data. https://www.fda.gov/media/96475/download. Accessed May 6, 2021

2. Centers 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.  

3. 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. 

4. 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.

Related Content

The BardyDx Carnation Ambulatory Monitor (CAM) is a P-wave centric wearable ambulatory cardiac patch monitoring and arrhythmia detection device. 

The BardyDx Carnation Ambulatory Monitor (CAM) is a P-wave centric wearable ambulatory cardiac patch monitoring and arrhythmia detection device. 

News | Cardiac Diagnostics | July 29, 2021
July 29, 2021 — A recent clinical study from Overlake Medical Center utilizing the Bardy Diagnostics Carnation Ambula
Ophthalmic optical coherence tomography (OCT) scan view of the macula in retina with vessels. Detecting heart disease with OCT imaging of the eye.Getty Images

Ophthalmic optical coherence tomography (OCT) scan view of the macula in retina with vessels. Getty Images
 

News | Cardiac Diagnostics | March 08, 2021
March 8, 2021 — In a new study from Shiley Eye Institute at UC San Diego Health, researchers have identified a potent
Alivecor's pocket ECG system allows consumers or cardiologists to record a single lead ECG. AI algorithms can determine if their ECG is normal or abnormal and identify the arrhythmia.

Alivecor's pocket ECG system allows consumers or cardiologists to record a single lead ECG strip on a smartphone. AI algorithms can determine if their ECG is normal or abnormal and identify the arrhythmia. 

News | Cardiac Diagnostics | March 03, 2021
March 3, 2021 — AliveCor recently announced a new collaboration with AstraZeneca to research new disease management s
A study of more than 100 million Americans in 3,123 counties found a correlation between cardiac death and their level of income. Getty Images Health disparities in cardiovascular disease.

A study of more than 100 million Americans in 3,123 counties found a correlation between cardiac death and their level of income. Getty Images

News | Cardiac Diagnostics | February 02, 2021
February 2, 2021 — A new study has found in the U.S.
A new study highlights the importance of continued public education regarding the risks of cigarette smoking and the failure of dual use with vaping to reduce cardiovascular risk. Getty Images

A new study highlights the importance of continued public education regarding the risks of cigarette smoking and the failure of dual use with vaping to reduce cardiovascular risk. Getty Images

News | Cardiac Diagnostics | January 06, 2021
January 6, 2021 — Smoking traditional cigarettes in addition to using e-cigarettes results in harmful health effects
The Mesuron Inc. Avalon-H90 uses magnetometers to detect myocarditis in patients without any physical contact. It uses ventricular repolarization dynamics analysis software to look for abnormalities. The vendor said it is more specific than using ECG. It detects the multidimensional dynamics of the electrical activity caused by differences in functions of electrical action potential of normal heart tissues and abnormal ones with hypoxia.

The Mesuron Inc. Avalon-H90 uses magnetometers to detect myocarditis in patients without any physical contact. It uses ventricular repolarization dynamics analysis software to look for abnormalities. The vendor said it is more specific than using ECG. It detects the multidimensional dynamics of the electrical activity caused by differences in functions of electrical action potential of normal heart tissues and abnormal ones with hypoxia. 

News | Cardiac Diagnostics | October 06, 2020
October 6, 2020 — A new technology being developed by U.S.-based Mesuron Inc.
With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a costly tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. Amyloidosis Patient Registry  #Amyloidosis

With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. This is Figure 2, showing how SPECT imaging allows the reader to distinguish between blood pool activity (ventricular cavity, etc) and myocardial activity and identify regional myocardial differences in radiotracer uptake.

News | Cardiac Diagnostics | March 05, 2020
March 5, 2020 — More than 300 patients have joined the Amyloidosis Patient Registry and it is now available to the en
heart disease image
News | Cardiac Diagnostics | December 18, 2019
December 18, 2019 — In their latest report, “...