A first-of-its-kind investigational medical device designed to alert a patient that they are having a heart attack or are very close to having one is now in a Pivotal Study. The AngelMed Guardian System, an implantable cardiac monitor and alerting system, is designed to reduce the time it takes patients to get to the emergency room during an impending heart attack. The device is designed to continuously monitor the heart’s electrical system and provide a warning to go to the ER when critical ST segment changes occur potentially even before they have heart attack symptoms.
More than a million heart attacks occur every year, and unfortunately, almost 1/3 of those are fatal. Many patients ignore or don’t recognize heart attack symptoms and don’t get to the hospital until three hours or more after symptoms occur. The medical community knows that “time is muscle.” And, there has been much effort made to decrease door to balloon time (the amount of time it takes a patient to get from the emergency room to having angioplasty or other treatment for an occluded artery). Unfortunately, there has been little decrease in mortality because patients continue to delay in seeking help or calling 911.
The Guardian System is currently part of the ALERTS Clinical study and is in 45+ medical centers across the country. The Study has world-renowned cardiologists as Lead Investigators, including Dr. Michael Gibson from Harvard, and Dr. David Holmes from Mayo Clinic.
Scientific evidence is beginning to confirm the potential benefits of the Guardian. An article was published in the August 2010 issue of JACC, Journal of the American College of Cardiology, that shows the Guardian can reduce the three hour average symptom-to-door time to as low as 20 minutes, and that every 30 minute reduction reduces mortality by 7.5% and congestive heart failure by 8.7%.
More than 200 patients have been implanted with the device in the Study to date, and up to 1000 will participate in total. You can speak with an AngelMed Senior Medical Executive. We also have a mother (63)and daughter (43) that have had the device implanted and are available for interviews to discuss their personal story.
The Guardian is already commercially available in Brazil and Europe. The founders of AngelMed are well known medical entrepreneurs who have original patents on pacing devices and defibrillators dating back to 60’s and 70’s.
For further information, please visit the Angel Medical Systems website at http://www.angel-med.com