The cardiac contractility boosting Optimizer Smart system is now approved for chronic, moderate-to-severe heart failure not suited for other heart failure device therapy, the FDA announced.
The device gained an indication to improve 6-minute walk distance, quality of life, and functional status for New York Heart Association class III heart failure with reduced ejection fraction (25% to 45%) that remains symptomatic on optimal medical therapy. Other required criteria were a regular heart rhythm and ineligibility for cardiac resynchronization therapy (QRS <120 ms on ECG).
Approval followed the overwhelmingly favorable recommendation in December by an FDA advisory committee for the implantable pulse generator using non-excitatory electrical pulses to increase ventricular contractile strength.
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