April 2, 2007 — Mount Sinai Medical Center, Miami Beach, FL, 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 multicenter 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.