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The US Food and Drug Administration (FDA) has approved another therapeutic device for patients with moderate-to-severe chronic heart failure, the Smart System Optimizer (Impulse Dynamics), the agency and the company announced today.
The indication specified relates to the improvement of the walking distance of 6 minutes, the quality of life and other aspects of the functional status of patients with symptomatic heart failure sinus rhythm despite optimal medical treatment.
The indication requires that patients do not meet the CRT criteria, which include those with narrow QRS intervals on electrocardiography, and that their left ventricular ejection fraction ( LVEF) ranges from 25% to 45%.
Impulse Dynamics notes that the Optimizer system, already available on the market in Europe, Brazil, India and elsewhere in the world, consists of a network of endocardial branches connected to a subcutaneous battery and a pulse generator. resembling a standard pacemaker.
He proposes a therapy that the company calls cardiac contractility modulation (CCM), consisting of pulses delivered to specific myocardial sites during the absolute refractive period of the cardiac cycle.
Stimulation does not cause the heartbeat, but it is thought that it reshapes myocardial biochemistry, first near the site of stimulation and more expansively in the long term, d? in a way that seems to ultimately improve overall contractile function, as previously described by theheart.org | Medscape Cardiology.
The FDA has based its approval on several randomized trials, including the FIX-HF-5C study, published last year. In various studies, Optimizer treatment has been badociated with significant improvements in LVEF, walking distance, and symptoms. The registry data suggest that it can reduce hospitalizations for heart failure and prolong survival.
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