The breakthrough device is indicated to improve 6-minute walk distance for certain patients with chronic heart failure.
The US Food and Drug Administration (FDA) has approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not able to receive treatment with other heart failure devices.
The system is indicated to improve the 6-minute walk distance, quality of live, and functional status of patients with marked limitation of physical activity who continue to have symptoms despite receiving medical treatment. Candidates for the implant must also have a regular heart rhythm, not be qualified for cardiac resynchronization therapy, and have left ventricular ejection fraction of 25% to 45%.
"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, director of the Division of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health.
The Optimizer Smart also received FDA Breakthrough Device designation. In December 2018, Impulse Dynamics (USA) announced that an FDA Advisory Committee voted unanimously that the benefits of the system outweigh the risks for the appropriate patients. The panel voted 12 to 1 that with the evidence available, there is reasonable assurance that the Optimizer Smart is safe.
"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," added Zuckerman.
The FDA’s approval decision was supported by results from 2 randomized clinical trials that included 389 patients with moderate-to-severe heart failure. Of those, 191 patients received the Optimizer Smart system implant in addition to the standard medical therapy provided to all participants.
Patients who received the Optimizer Smart system implant improved the distance they could walk in 6-minute walk tests compared to patients who only received medical therapy. Additionally, patients in the device arm improved on measurements of heart failure symptoms including quality of life assessments and measures of the effect the symptoms have on daily physical activities.
Potential safety concerns associated with use of the Optimizer Smart system include infection, bleeding, and worsened heart failure. There are also possible complications with the device itself, such as a dislodgement or fracture of the 3 leads that are implanted in the heart.