Prairie Education and Research Cooperative Announces ALERTS Pivotal Study for Implantable Cardiac Monitor and Alert System

Contact: Gwen St. Clair, Prairie Education and Research Cooperative, (217) 492-9100, ext 123. 

New study will evaluate safety and effectiveness of an implantable device, designed to reduce patient time to the ER and improve survival rates from heart attack in high-risk patients.

SPRINGFIELD: Ziad Issa, M.D., Prairie Education and Research Cooperative, and St. John’s Hospital, announced its participation in the ALERTS Pivotal US 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 the 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 AngelMed Guardian system is investigational; it has yet to be approved by the FDA. The objective of the ALERTS Pivotal Study is to provide an assessment of the safety and effectiveness of the AngelMed Guardian System.

Ziad Issa, MD of Prairie Cardiovascular Consultants serves as the Principal Investigator for this critical study “Shortening the response time for suspected heart attack can substantially reduce the burden of cardiac damage and save many lives each year. Although our in-hospital treatment strategies have been very effective in delivering prompt treatment for patients with acute heart attacks once they present to the emergency room, the interval between symptom onset and definitive treatment remains significantly long. The major component of this delay is the time it takes the patient to recognize the seriousness of his symptoms and decide to go to the emergency room. The ALERTS Pivotal Study is designed to evaluate a new tool to help shorten the symptom-to-treatment delay. We are excited to participate in this important clinical trial."

According to the American Heart Association, one of every five deaths in the US is attributable to coronary heart disease. Further, 50% 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. The device warns patients to seek immediate medical care using vibratory, auditory, and visual alerts – often before symptoms manifest.

"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."

Prairie Education and Research Cooperative/St. John’s Hospital is among the first medical facilities to participate in the AngelMed Guardian system trial. To participate in the ALERTS study, patients must meet various inclusion criteria.

Forward Looking Statements: Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the Company's products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.