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Mount Sinai Medical Center Implants First New Device for Heart Failure Patients in Florida
Device Part of National Investigational Study; Physicians Seeking Patients to Enroll
| Source: Mt. Sinai Medical Center
MIAMI BEACH, FL -- (MARKET WIRE) -- March 29, 2007 -- Mount Sinai Medical Center has implanted
one of the first of a new device intended to strengthen the heartbeat of
patients with heart failure. The pacemaker-like device called The
Optimizer™ System is a pulse generator designed to deliver electrical
impulses to the heart for treatment of moderate to severe heart failure.
The device is the focus of a national multi-center trial to investigate its
safety and effectiveness. This study is sponsored by Impulse Dynamics
(USA) Inc., a specialty medical device company located in New York. Mount
Sinai is only one of two Florida hospitals involved in the trial and is the
first clinical site in Florida to implant the device. The hospital is
continuing to look for patients with heart failure who want to participate.
The investigational study, called FIX-HF-5 (Fix Heart Failure 5), is
designed to investigate the effects of the Optimizer System in over 420
Class III or Class IV heart failure patients at up to 50 U.S. sites. Heart
failure afflicts more than five million Americans and an estimated 15
million patients worldwide. It is a life-threatening condition caused by a
weak heart in which patients accumulate excess fluid, become short of
breath, and may die prematurely.
"In spite of the advances made over the last 15 years, heart failure
remains a common cause of death or disability. This project tests one of
the most exciting potential advances in the device therapy field," said
Gervasio A. Lamas, M.D., director of Cardiovascular Research and Academic
Affairs at Mount Sinai Medical Center in Miami Beach. "This novel therapy
stimulates the heart as it is beating, which appears to make the heart beat
more strongly. It could really make a positive impact in the quality of
life for millions of people who suffer from heart failure." Unlike a
pacemaker, the Optimizer signals do not initiate a heartbeat; rather, its
signals are intended to enhance the strength of the heart.
"With our first two implants complete we are excited about being able to
fully assess the potential of this device to determine if it will improve
the life of heart failure patients," said Todd Florin, M.D., co-director of
Electrophysiology at Mount Sinai.
"This is intended for patients who are not eligible for other traditional
forms of device treatment such as cardiac resynchronization," said Joseph
Zebede, M.D., co-director of Electrophysiology at Mount Sinai. "Should it
prove safe and effective, this device will provide great hope to heart
failure patients."
Patients enrolled in the FIX-HF-5 must be older than 18 years of age; have
received standard heart failure therapy for at least 90 days; be able to
complete exercise tolerance tests; have an ejection fraction less than or
equal to 35 percent, and be willing to return for follow up.
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. Common symptoms of heart failure include
shortness of breath, fatigue, weakness, persistent coughing and difficulty
performing everyday tasks such as grocery shopping or climbing stairs.
Another sign of heart failure is the accumulation of fluid in the legs,
feet, abdomen, lower back and lungs. 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 Mount Sinai Medical Center
Mount Sinai Medical Center is South Florida's largest private, independent,
not-for-profit teaching hospital. For decades Mount Sinai has been a
leader in cardiac research -- leading the way in helping to uncover new
methods of treating and preventing heart disease. The medical center
currently has some 30 cardiac research programs underway to study the gamut
of cardiac surgery and care, from alternative therapies to pacemaker
effectiveness.
As has been its tradition, Mount Sinai remains committed to providing
excellent medical care, progressive education and probing research, while
remaining at the forefront in state-of-the-art technology, diagnostics and
treatment. This tradition of excellence has made Mount Sinai a leader among
health care providers in the United States, the Caribbean and Latin
America.