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The Heart Group of Lancaster General Health Announces ALERTS Pivotal Study for Implantable Cardiac Monitor and Alert System

8/16/2012 9:59:56 AM

New research 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.


Lancaster, PA July,  2012:  The Heart Group of Lancaster General Health announced its participation in the ALERTS Pivotal US trial for the AngelMed Guardian implantable cardiac monitor and alert system.


The AngelMed Guardian System is designed to track significant changes in the heart's electrical signal and then alert patients to seek immediate medical attention. This should reduce the time it takes patients to get to the emergency room. 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 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 Dr. Seth Worley, Principal Investigator for the ALERTS Study at Lancaster General Health. “We are excited to participate in this important clinical trial.”


According to the latest American Heart Association statistics, one out of every six deaths in the US was attributable to coronary heart disease. Each year, an estimated 785,000 Americans will have a new coronary attack, and 470,000 will

have a recurrent attack. Approximately every 34 seconds, an American will have a heart attack. It is also estimated that an additional 195,000 silent first myocardial infarctions occur each year.


The AngelMed Guardian System is comprised of the following patient components: an internal implantable device, a standard pacemaker lead, and an external telemetry device.


There is also a programmer that is used to wirelessly program and retrieve data stored in the implantable device.


"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."


The Heart Group of Lancaster General Health 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. For more information on the

AngelMed Guardian system or the ALERTS study protocol, contact Kay Knepper at 717-544-5951 or kmkneppe@lghealth.org


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.


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