The U.S. Food and Drug Administration has approved a new treatment option on Thursday for people with chronic heart failure that they're calling a 'breakthrough device'.
The Optimizer Smart system allows for the treatment of patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices. The FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease in patients who can't get adequate benefits from standard treatments.
“Patients with moderate-to-severe chronic heart failure have limited treatment options," aid 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 is comprised of several components, including an implantable pulse generator, battery charger, programmer and software. The pulse generator is implanted under the skin in the upper left or right area of the chest and connected to three leads that are implanted in the heart.
About 5.7 million people in the United States have heart failure, a condition in which the heart cannot pump enough blood to meet the body's needs. The leading causes of heart failure are diseases that damage the heart, such as high blood pressure and diabetes.