FDA Approves Optimizer Implant for CRT-Ineligible Heart Failure
The US Food and Drug Administration (FDA) has approved another device therapy for patients with chronic moderate to severe heart failure, the Optimizer Smart System (Impulse Dynamics), the agency and the company announced today.
The specified indication is for improving 6-minute walk distance, quality of life, and other aspects of functional status of patients with symptomatic heart failure in sinus rhythm despite optimal medical therapy.
The indication requires that patients not qualify for cardiac resynchronization therapy (CRT), which would include those with narrow QRS intervals on electrocardiography, and to have a left ventricular ejection fraction (LVEF) of 25% to 45%.
Impulse Dynamics notes that the Optimizer system, which is already on the market in Europe, Brazil, India, and elsewhere around the world, consists of an endocardial lead array connected to a subcutaneous battery and pulse generator that resembles a standard pacemaker.
It delivers a therapy the company calls cardiac contractility modulation (CCM), consisting of pulses delivered to specific myocardial sites during the cardiac cycle's absolute refractory period.
The stimulation doesn't engage cardiac rhythm but is believed to remodel myocardial biochemistry, first near the stimulation site and more expansively over long-term use in a way that seems to eventually improve global contractile function, as previously described by theheart.org | Medscape Cardiology.
The FDA based its approval on several randomized trials, including the FIX-HF-5C study, which was published last year. Collectively in different studies, Optimizer treatment has been associated with significant improvements in LVEF, walk distance, and symptoms. Registry data have suggested it can cut heart-failure hospitalizations and prolong survival.
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