The world's first and only heart attack warning system
24/7 monitoring with real-time heart attack detection and patient alerts
The GUARDIAN is an implantable cardiac monitoring device which alerts the patient when a potential ACS event is detected, even in the absence of symptoms.
Programmed to match the individual patient, the GUARDIAN monitors the patient’s heart 24/7 and alerts the patient upon detection of signals related to acute coronary syndrome (ACS) events so the patient can seek medical care without delay.
For patients who have had a prior cardiac event and are at high risk of a recurrent event
The GUARDIAN is indicated for use in patients who have had prior acute coronary syndrome (ACS) events and remain at high risk for recurrent ACS events.
Get to the ER faster for critical care
Reducing pre-hospital delay improves your heart’s chances of obtaining benefit from medical treatment. The Guardian helped get patients to the ER in under 2 hours1.
A delay in critical care increases the risk of permanent heart damage and heart failure. In clinical studies, Guardian patients arrived at the hospital about 6 hours earlier than patients relying on symptoms alone2.
The GUARDIAN device fills an unmet medical need by providing more effective diagnosis of a life-threatening condition when compared to patient symptoms alone
FDA Summary of Safety and Effectiveness Data (SSED) on file at Hydrix
References
1. David R. Holmes, Mitchell W. Krucoff, Chris Mullin, Ghiath Mikdadi, Dale Presser, David Wohns, Andrew Kaplan, Allen Ciuffo, Arthur L. Eberly, Bruce Iteld, David R. Fischell, Tim Fischell, David Keenan, M. Sasha John, C. Michael Gibson, Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events, Journal of the American College of Cardiology, Volume 74, Issue 16, 2019, Pages 2047-2055, https://doi.org/10.1016/j.jacc.2019.07.084.
2. C. Michael Gibson, David Holmes, Ghiath Mikdadi, Dale Presser, David Wohns, Megan K. Yee, Andrew Kaplan, Allen Ciuffo, Arthur L. Eberly, Bruce Iteld, Mitchell W. Krucoff, Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction, Journal of the American College of Cardiology, Volume 73, Issue 15, 2019, Pages 1919-1927. https://doi.org/10.1016/j.jacc.2019.01.014.