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FDA approves new device for treating moderate to severe chronic heart failure in patients

Press releases may be edited for formatting or style | March 22, 2019 Cardiology
The U.S. Food and Drug Administration today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. The FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

“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, M.D., director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “The FDA recognized the unmet need for these patients and worked with the manufacturer through our Breakthrough Device Program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness.”

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. Treatment for heart failure includes treating the underlying causes and reducing symptoms such as fatigue and swelling in the lower extremities that make physical activity difficult. Doctors may prescribe medications like angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers or beta blockers to lower blood pressure and reduce strain on the heart as well as diuretics to reduce fluid buildup in the lungs and swelling in the feet and ankles.

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. After the device is implanted, a physician tests and programs the device, which delivers electrical impulses to the heart during regular heartbeats to help improve the heart’s squeezing capability.

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