Spectrum Health Heart Study Tests Early Warning Device for At-Risk Patients

Clinical Trial at Fred and Lena Meijer Heart Center To Assess Monitor

A new study will evaluate the safety and effectiveness of a heart device designed to warn patients of impending heart trouble and prompt them to seek medical care.

Cardiologists and staff at the Spectrum Health Fred and Lena Meijer Heart Center are participating in a clinical trial of an implantable cardiac monitor. It is designed to hasten a trip to the emergency department and improve survival rates for heart attacks in high-risk patients who have already had a significant cardiac event.

Patients are being enrolled in the ALERTS U.S. trial for the AngelMed Guardian implantable cardiac monitor and alert system. The monitoring system is designed to track significant changes in the heart’s electrical signal and then alert patients to immediately seek medical attention. The objective of the ALERTS study is to provide an assessment of the safety and effectiveness of the AngelMed Guardian System.’

The Meijer Heart Center is among the first hospitals in the country to participate in this trial. One patient has already had a device implanted – only the fifth person in the U.S. to receive this implant as part of this trial.

“This study could benefit some of our patients who are at high risk of having a heart attack,” said cardiologist David Wohns, MD, the principal investigator of the study and medical director of catherization labs at Spectrum Health. “The device is designed to alert the patient at the earliest onset of a heart attack so that they can get treatment as soon as possible. It could potentially save lives and change the way we care for these patients.”

According to the American Heart Association, one of every five deaths in the US is a result of coronary heart disease. In addition, 50 percent of heart-attack fatalities occur within one hour of symptom onset and also occur before the patient even reaches the hospital.

“Studies have shown that most of the damage to the heart occurs during the first two hours after a coronary blockage,” said Jonathan Harwood , AngelMed’s chief operating officer. “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 hospital workstation that aids physicians in evaluating heart signals.

Wohns said that a heart attack is typically the result of a blood clot closing a coronary artery. When this happens, there is a shift in the electrical signal of the heart. The shift in this signal is caused by the electrical difference between the portion of the heart muscle not getting oxygen due to the clogged artery and the rest of the heart that is still receiving oxygen.

To participate in the ALERTS study, patients must meet various criteria. For more information on the AngelMed Guardian system or the ALERTS study protocol, contact the Spectrum Health Research Department at 616-391-9356 or research.department@spectrum-health.org.

Forward looking statements from AngelMed Guardian manufacturer: 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.

Spectrum Health is a not-for-profit health system in West Michigan that offers a full continuum of care through the Spectrum Health Hospital Group, a collection of seven hospitals and more than 140 service sites; the Spectrum Health Medical Group, a multispecialty team of nearly 100 providers; and Priority Health, a health plan with nearly 500,000 members.

Spectrum Health’s 14,000 employees, 1,500 medical staff members and 2,000 volunteers are committed to delivering the highest quality care to those in medical need.’ The organization provided $111.1 million in community benefit during its 2008 fiscal year. As a system, Spectrum Health has earned more than 100 awards during the past 10 years.