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.
The Optimizer had “breakthrough device” designation from the FDA for filling an unmet clinical need for this population that couldn’t get other implantable devices.
“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” said Bram Zuckerman, MD, of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, in a press release.
The system is comprised of an implanted pulse generator with three leads, battery charger, programmer, and software. Potential risks include infection, bleeding, worsened heart failure, device dislodgement, and lead fracture.