The Food and Drug Administration approved the Optimizer Smart system last week as a treatment for those with moderate-to-severe heart failure.
The FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease, in this case heart failure, and addresses an unmet medical need.
“Patients with moderate-to-severe chronic heart failure have limited treatment options,” said Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “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.”
The Optimizer Smart system has an implantable pulse generator, battery charger, programmer and software. The FDA evaluated data from two randomized, multicenter clinical trials with a total of 389 patients with moderate-to-severe heart failure.
Patients receiving the Optimizer showed improvements in the distance they were able to walk in six-minute walking tests and improvements on standard assessments to measure heart failure symptoms, such as how much the symptoms affect a patient’s quality of life, the FDA said.
