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Format: 04/19/2014
Format: 04/19/2014

News

Allegheny General Hospital Announces Launch of Study Exploring Implantable, Early Heart Attack Warning Device

Wednesday, March 14th, 2012

Heart disease specialists at Allegheny General Hospital (AGH) have joined a landmark clinical trial investigating the potential of a novel implantable technology that is designed to provide patients with coronary artery disease early warning of an impending heart attack. AGH is the only Pittsburgh area hospital and among a select group in the country testing the new device, called the AngelMed Guardian System, as a participant in the ALERTS Pivotal US Study.

According to David Lasorda, DO, FACC, Director of AGH’s Division of Interventional Cardiology and the hospital’s principal investigator in the ALERTS study, the AngelMed Guardian System monitors the heart’s electrical signals and alerts patients to seek medical attention if alterations in those signals indicate the possibility of an adverse coronary event.

The objective of the ALERTS Pivotal Study is to assess the safety and effectiveness of the technology.

“We are very excited to play a major role in the evaluation of this promising technology.
Patient outcomes following heart attack are largely dependent upon how quickly the
cardiac injury is diagnosed and therapeutic efforts are initiated to restore blood flow to
the heart. Delays in that process can result in permanent damage to heart muscle,”
Dr. Lasorda said.

“If the Guardian system proves to be effective in helping us detect the onset of a heart attack
in its earliest phases, we may be able to introduce a dramatic new paradigm in the treatment
of this extremely prevalent and deadly disease,” he said.

The American Heart Association estimates that one of every five deaths in the United States is attributable to coronary heart disease. Furthermore, 50% of heart-attack fatalities occur within one hour of symptom onset and often before the patient even reaches the hospital.

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

The system is designed to detect rapid ST segment changes – ST shifts – that may signify
major cardiac events, such as coronary artery blockages caused by life-threatening
vulnerable plaque ruptures. Once a ST shift is detected, the system alerts patients by
delivering a series of vibratory, auditory and visual warnings.

When the AngelMed Guardian System’s emergency alarm is triggered, the implanted device
in the patient’s chest vibrates and the external hand held device beeps and flashes a red light.
Patients using the device are advised to call 911 and seek immediate medical attention if the emergency alarm occurs.

"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 AngelMed Guardian System also stores EKG traces for additional clinical analysis of the patient’s cardiovascular function.

To participate in the ALERTS study, patients must meet various inclusion criteria. Those interested in learning more about the AngelMed Guardian System or the ALERTS study protocol can contact Joe Carothers at 412-359-4156 or Kenneth Rayl at 412-359-6860.

 

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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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