Heart failure treatment company Impulse Dynamics said on Wednesday that the first heart failure patient has been implanted with the Optimizer Smart System at the Ohio State University Wexner Medical Center following the US Food and Drug Administration's approval.
According to the company, the Optimizer Smart System is the first and only CCM (Cardiac Contractility Modulation) device approved by the US FDA to improve six-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients, who are not indicated for CRT and have an LVEF ranging from 25% to 45%. Only 30% of moderate to severe chronic heart failure patients are candidates for CRT.
The patient, a 69-year-old man, was diagnosed with heart failure five years ago. Despite receiving optimal drug therapy, the patient's heart failure progressed, but he was not a candidate for CRT.
Prior to conducting the first implant, Ohio State University Wexner Medical Center played an integral part in the clinical testing of the company's Optimizer Smart System.The Optimizer Smart System administers its proprietary CCM therapy to the heart. CCM is a unique electrical pulse delivered during the absolute refractory period, which is just after the heart contracts. CCM works by modulating the strength of the heart muscle contraction rather than the rhythm.
Impulse Dynamics' Optimizer System has been implanted in over 3,500 patients and is currently available in Europe, China, Brazil, India and more than 40 other countries.
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