Presentation will focus on clinical information on the new AngelMed Guardian implantable device, designed to reduce patient time to the ER and improve survival rates from heart attacks in high-risk patients.

Angel Medical Systems has announced that Dr. David Fischell, Chief Executive Officer, will be the first featured speaker at the upcoming Out-of-the-box “Session Innovation@EuroPCR09” on May 19 in Barcelona, Spain. EuroPCR is the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Dr. Fischell’s presentation will highlight data from recent human clinical studies showing the AngelMed Guardian System’s ability to detect vulnerable plaque rupture. "When someone has a heart attack, it is typically the result of a blood clot closing one of the three major coronary arteries. When this happens, there is a shift in the ST segment of the heart signal caused by the electrical difference between the portion of the heart muscle fed by the closed artery and the rest of the heart that is still receiving oxygen," says Dr. Fischell.

The Guardian System is designed to internally monitor ECG signals in real time, 24-hours-a-day, to detect these ST shifts resulting from coronary occlusions. The System is comprised of an internal implantable device about the size of a pacemaker with a single pacemaker lead into the heart, an external pager-like alerting device, and a programmer that lets physicians read out the heart signals.

Early clinical cases have shown the Guardian System’s ability to detect plaque ruptures in patients and warn them to seek immediate medical attention. "Experimental and clinical studies have shown that most of the damage to the heart occurs during the first two hours after coronary occlusion," adds Dr. Fischell. "This device has the potential to warn patients hours — perhaps even days — before a heart attack occurs."

The Guardian System is currently available commercially in Brazil, and is in the ALERTS Phase II Pivotal trial in clinical sites across the United States. The first implants in the ALERTS trial took place in December, 2008 with sites across more than 10 states now enrolling patients in the study. Angel Medical is currently ISO 13485 certified and is working with a notified body to gain CE mark approval.

For more information on the AngelMed Guardian System or the ALERTS study in the United States, go to http://www.angel-med.com.