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Deaconess Medical Center Seeks Heart Failure Patients For Investigational Study Evaluating Use Of New Implantable Pulse Generator


10/19/2005 5:09:06 PM

SPOKANE, Wash., Aug. 8 /PRNewswire/ -- Deaconess Medical Center announced today it is enrolling patients in a clinical research study and has performed its first implant to investigate the safety and effectiveness of an investigational implantable pulse generator called the Optimizer(TM). The Optimizer(TM) System is designed to deliver electrical impulses to the heart for treatment of moderate to severe heart failure. This study of the Optimizer System is sponsored by Impulse Dynamics (USA) Inc., a specialty medical device company located in New York and a wholly-owned subsidiary of Impulse Dynamics N.V.

Heart failure is a disease caused by weak or damaged heart muscle that is unable to pump enough blood throughout the body. If proven safe and effective, the Optimizer System has the potential to help treat heart failure in a large number of patients.

"The Optimizer System is an exciting technology with the potential to treat patients with Class III or Class IV heart failure," said Dr. Harold Goldberg, principal investigator of the study. "This technology provides a unique approach to heart failure that may benefit patients who are not candidates for standard treatments. We have already begun enrolling patients and have successfully performed the first implant at Deaconess in the FIX-HF-5 study to evaluate the safety and effectiveness of the Optimizer. We look forward to completing new patient enrollment in order to fully assess the potential of this device to meet the needs of moderate to severe heart failure patients."

The investigational study, called FIX-HF-5 (Fix Heart Failure 5), is designed to investigate the effects of the OPTIMIZER(TM) System in approximately 400 New York Heart Association (NYHA) Class III or Class IV heart failure patients at up to 50 U.S. sites.

About Heart Failure

Heart failure is a disease that afflicts over 5 million Americans and an estimated 15 million patients worldwide. It is one of the most common causes of hospitalization and a growing and costly burden to the healthcare system. It is estimated that the U.S. healthcare system will spend a projected $28.8 billion on caring for heart failure patients in 2005.

Symptoms of heart failure result when the heart that is unable to pump enough blood to meet the energy needs of the body. A failing heart most often results from damage to the heart muscle due to injuries such as heart attack, untreated coronary artery disease or persistent high blood pressure. It can also occur as a result of genetic and/or molecular abnormalities or infections. The most common forms of heart failure are treated with drugs and electrical devices such as pacemakers and implanted defibrillators, but if symptoms continue to worsen, other therapies are needed.

About Deaconess Medical Center

Deaconess Medical Center is a fully accredited, 388-bed hospital located in the heart of downtown Spokane, Washington. Deaconess has been named a Solucient Top 100 Heart Hospital three times out of the last five years. Deaconess is a part of the Empire Health Services (EHS) family, a not-for-profit multi-service healthcare provider. EHS owns and operates Deaconess Medical Center, Valley Hospital and Medical Center and four urgent care centers. For more information, please visit www.empirehealth.org.

Deaconess Medical Center

CONTACT: Media - Christine Varela, Public Relations Coordinator,+1-509-473-7692, Mobile: +1-509-435-1839, varelacm@empirehealth.org


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