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BryanLGH Heart Institute Participating in Investigational Study Evaluating Use Of Implantable Pulse Generator

Posted on: Thursday, 4 August 2005, 09:01 CDT

LINCOLN, Neb., Aug. 4 /PRNewswire/ -- BryanLGH Heart Institute today announced it is participating in a clinical study and has performed its first successful implant to investigate the safety and effectiveness of a new 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 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.

Heart failure is a disease caused by a 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. Andrew Merliss, Principle Investigator. "We have already begun enrolling patients in the FIX-HF-5 Study to evaluate the safety and effectiveness of the Optimizer System. 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 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

Symptoms of heart failure result when the heart 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 BryanLGH Heart Institute

The BryanLGH Heart Institute (BHI) is a cardiovascular medical group specializing in cardiology and cardiovascular and thoracic surgery. BHI is dedicated to the most advanced diagnosis and treatment of heart disease while remaining patient focused. We focus on personal relationships with patients and communities while providing the most effective cardiovascular care available.

BHI is currently staffed with eleven physicians serving a four-state region, based in Lincoln, Nebraska. Services are routinely performed in more than 30 communities.

BryanLGH Heart Institute

CONTACT: Dr. Andrew Merliss, Principle Investigator, +1-402-483-3333, orJill Domsch, Public Relations, +1-402-483-3333, jill@bhi-1.com; both forBryanLGH Heart Institute

Source: PRNewswire

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