Swedish Participating in Study to Evaluate Safety, Effectiveness of Implantable Device Designed to R

Swedish Participating in Study to Evaluate Safety, Effectiveness of Implantable Device Designed to Reduce Patient Time to the ER, Improve Survival Rates from Heart Attack in High-Risk Patients

SEATTLE, Oct. 10, 2011 – In early January 2010 Swedish became the first medical center in western Washington to begin participation in the ALERTS Pivotal U.S. Trial for the AngelMed Guardian implantable cardiac monitor and alert system. The system is designed to reduce the time it takes patients to get to an emergency room during an impending heart attack.

The AngelMed Guardian System ® is designed to track significant changes in the heart’s electrical signal and then alert patients to seek medical attention. The objective of the ALERTS Pivotal Study is to provide an assessment of the safety and effectiveness of the AngelMed Guardian System.

“If the Guardian system proves to be effective in the early detection and warning of potentially life-threatening heart conditions, we may be able to shift the paradigm for early treatment at the onset of heart attacks,” said Swedish Heart & Vascular Institute interventional cardiologist Mark Reisman, M.D., principle investigator for this study at Swedish. “We are excited to be participating in this important clinical trial.”

According to the American Heart Association, one of every five deaths in the United States is attributable to coronary heart disease. Further, 50 percent of heart-attack fatalities occur within one hour of symptom onset and occur before the patient even reaches the hospital.

“Experimental and clinical studies have shown that most of the damage to the heart occurs during the first two hours after coronary occlusion,” says AngelMed’s Chief Operating Officer Jonathan Harwood. “We’ve designed the device to warn patients of this and other cardiac events hours – perhaps days – before they occur.”

The AngelMed Guardian System is comprised of an internal implantable device about the size of a standard pacemaker with a lead into the heart, an external telemetry device, and a programmer that aids physicians in evaluating heart signals.

“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,” adds AngelMed’s CEO, David Fischell, Ph.D. “The ALERTS trial is designed to test the Guardian’s ability to detect this electrical shift in a clinical setting and then provide an early warning to patients that could potentially save their lives.”

To participate in the ALERTS Study, patients must meet various inclusion criteria. For more information about the ALERTS Study at Swedish, contact Inger Rasmussen at 206-215-3989 or via inger.rasmussen@swedish.org.

For more information about the AngelMed Guardian System, visit www.angel-med.com.

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Media Coverage

  • To watch a related story online that KING Television (Channel 5, NBC) aired on Oct. 11, 2011, click here
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