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HEART CENTER ENROLLING PATIENTS IN NEW IMPLANTABLE CARDIAC DEVICE TRIAL
The Heart Center at New York-based St. Francis Hospital has announced that it is enrolling patients in a clinical study to investigate the safety and effectiveness of a new implantable pulse generator called the Optimizer, manufactured by Impulse Dynamics.
The Optimizer is designed to deliver electrical impulses to the heart for treating moderate-to-severe heart failure. The 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 Class III or Class IV heart failure patients at up to 50 U.S. sites.
"The Optimizer is an exciting and innovative technology with the potential to treat patients with Class III or Class IV heart failure," said principal investigator Steven Greenberg. "We have already begun enrolling patients 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."
KEYWORDS FDAnews Device Daily Bulletin
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