The U.S. Food and Drug Administration (FDA) has approved Impulse Dynamics’ Optimizer Smart system for delivering cardiac contractility modulation therapy for patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices.
The Optimizer Smart system was granted breakthrough device designation in 2015 because it treats heart failure — a life-threatening disease — and addresses an unmet medical need in patients who do not get the benefits from standard treatments and have no alternative treatment options.
The system is made up of an implantable pulse generator, battery charger, programmer and software. The pulse generator gets implanted under the skin in the upper left or right area of the chest and connects to three leads that are implanted in the heart. Once implanted, a physician tests and programs the device, which delivers electrical impulses to the heart during regular beat to improve the heart’s squeezing capability.
The FDA evaluated data from two randomized clinical trials with 389 patients with moderate to severe heart failure.
In the trials, all patients received optimal medical therapy and 191 also had an Optimizer Smart system implant. Patients with the implant had improvements in the distance they could walk in six-minute tests and on standard assessments to measure heart failure symptoms.
The device is intended for patients who have a marked limitation of physical activity and remain symptomatic despite receiving optimal medical therapy. Patients should also have a regular heart rhythm, not be candidates for cardiac resynchronization therapy and have a left ventricular ejection fraction of 25 to 45 percent.
Close to 5.7 million people in the U.S. have heart failure and often have limited treatment options, which can affect quality of life and limit their physical activity, according to 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 the market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Zuckerman said.
Photo courtesy of Impulse Dynamics.
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