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Holy Cross Hospital Announces ALERTS Pivotal Study for Implantable Cardiac Monitor and Alert System

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Holy Cross is the First Hospital in South Florida to offer a new study evaluating the 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

Fort Lauderdale, FL - Holy Cross Hospital in Fort Lauderdale 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 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 Rishi Anand, MD, Principal Investigator. “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 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."

Holy Cross Hospital is the first medical facility in South Florida 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 954-229-8400.

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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