Healthcare Industry News:  Impulse Dynamics 

Devices Cardiology

 News Release - April 19, 2006

St. Paul Heart Clinic Seeks Heart Failure Patients for Investigational Study Evaluating Use of New Implantable Pulse Generator

Now Enrolling Patients in New Implantable Cardiac Device Trial

ST. PAUL, Minn., April 19 (HSMN NewsFeed) -- St. Paul Heart Clinic, today announced it is enrolling patients in a clinical study 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. This investigational study is called the FIX-HF-5 (Fix Heart Failure 5).

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 $29.6 billion on caring for heart failure patients in 2006.

Heart failure is 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.

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.

"The Optimizer System is an exciting technology with the potential to treat patients with advanced heart failure," said Dr. Alan Bank, principal investigator of the study. "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."

Since 1974 St. Paul Heart Clinic has served patients and referring physicians from Minnesota and western Wisconsin. Today, St. Paul Heart Clinic is one of the largest, most active cardiovascular centers in the region. Thirty-three cardiologists provide specialized care in virtually all aspects of cardiology. In order to bring the latest medical technology to its patients, the St. Paul Heart Clinic is involved in over 40 clinical research trials. For more information regarding participating in a clinical research trial, please visit the St. Paul Heart Clinic website at or call (651) 726-2767.

Source: St. Paul Heart Clinic

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