Angel Med Systems
Kelly J. Tucker, MD
Orange County Heart Institute &
of World’s First and Only Implantable Cardiac Monitor and Patient Alerting System for Acute Coronary Syndromes (ACS) after its
Participation in the ALERTS Clinical Study
The ‘AngelMed Guardian System’ Designed to Warn
High Risk Patients of Potential ACS (MI or Unstable Angina)
ORANGE COUNTY HEART INSTITUTE & RESEARCH CENTER, ORANGE CA, May 11, 2018 - Dr. Kelly Tucker of Orange County Heart Institute & Research Center announces that the ‘AngelMed Guardian® System’. has received U.S. Food and Drug Administration (FDA) premarket approval (PMA).
The AngelMed Guardian System is an implantable cardiac monitor with patient alerting capability and an additional external alarm device. It is indicated for use in patients who have had prior ACS events including myocardial infarctions (heart attacks) or unstable angina and who remain at high risk for recurrent ACS events. The Guardian System is an adjunct to patient recognized symptoms by detecting potential ongoing ACS events, characterized by sustained ST segment changes, and alerting the patient to seek medical attention for those events.
Approval of the ‘AngelMed Guardian System’ by the U.S. FDA was based on preclinical and clinical data, including data derived from the ALERTS Clinical Study that began in 2009. Orange County Heart Institute & Research Center was among the one hundred centers across the
"The AngelMed system represents a huge move forward in medical technology and allows physicians now for the first time to detect silent events. This is going to save hundreds of thousands of lives each year. It's a wonderful device." said Orange County Heart Institute & Research Center Electrophysiologist, Dr. Kelly J. Tucker.
“We are so thankful to Dr. Kelly J. Tucker, Principle Investigator and Karena De La Mora, Research Coordinator at Orange County Heart Institute & Research Center for all of their efforts during the ALERTS Clinical Study. Without their dedication and hard work, we would never have reached approval. We will also be forever thankful to the patients who participated in our clinical study. We have worked tirelessly to bring this device to market to fill this unmet need that addresses a life-threatening condition and may improve their quality of life." said Angel Medical System’s Chief Executive Officer, Dr. David R. Fischell.
The national principal investigator for the ALERTS pivotal clinical study, Dr. C. Michael Gibson of
"Helping our patients was always foremost in our minds and hearts." said Angel Medical System’s Chief Operating Officer, David Keenan.
The Guardian System is implanted like a pacemaker, typically in less than an hour under a local anesthetic. This well-studied implantation technique demonstrated an adverse event rate that was also very similar to the rate seen for pacemaker implants. The types of adverse events seen were also similar to those seen with pacemaker implants.
About Coronary Heart Disease and Heart Attacks
According to the American Heart Association, one of every five deaths in the
In the ALERTS Clinical Study, the median time from symptom onset to arrival at the hospital for a heart attack was one hour.
About Angel Medical Systems, Inc.
Angel Medical Systems, Inc. was founded in 2001 by Drs. Robert, Tim and David Fischell, active serial entrepreneurs and inventors of medical devices. In 1999, the company filed its first of more than 50 issued US patents relating to detecting cardiac events and patient alerting, with the company’s first human implant occurring in 2005.
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