The FDA has approved the Optimizer Smart system as an implantable treatment option for heart failure patients with left ventricular ejection fraction between 25 and 45 percent who aren’t candidates for cardiac resynchronization therapy (CRT).
Both the FDA and device manufacturer Impulse Dynamics announced the approval on March 21. The Optimizer Smart system was granted a breakthrough device designation in 2015 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,” the FDA said in its announcement.
According to Impulse Dynamics, the device features a technology called Cardiac Contractility Modulation, or CCM, which is a “unique electrical pulse delivered during the absolute refractory period.”
“In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm,” the company’s press release stated.
In December, it became the first breakthrough device to go before the Circulatory Systems Device Panel of the FDA’s Medical Devices Advisory Committee and received a 12-0 vote on its benefit-to-risk ratio.
The FDA’s approval was supported by two randomized trials including 389 patients with moderate-to-severe heart failure. All of them were on optimal medical therapy but 191 patients were also implanted with an Optimizer Smart system. Those patients showed significant improvements on a six-minute walking test, a quality-of-life assessment and measures of functional status, according to the FDA.
“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,” Bram Zuckerman, MD, director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the announcement.
“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.”
Impulse Dynamic plans to launch the device in the U.S. later this year. It’s already available in Europe, China, Brazil, India and more than 40 other countries, according to the release.
The FDA said potential complications with the Optimizer Smart system include device infection, bleeding, worsened heart failure, device dislodgement or lead fracture.