CVRx said today it won FDA approval for its Barostim Neo system, the world’s first heart failure neuromodulation device.
The Minneapolis-based company’s device is designed to improve symptoms in patients with advanced heart failure who are not suited for other heart failure devices by electrically activating the baroreflex to reduce sympathetic activity and increase parasympathetic activity.
A randomized clinical trial included 130 participants receiving a Barostim Neo, compared to 134 people who stayed on guideline-directed medical therapy. The trial concluded that patients who received a Barostim Neo had improved quality of life, exercise capacity and functional status relative to their New York Heart Association (NYHA) class.
The device was approved on the PMA pathway and earned breakthrough designation in 2015. CVRx will be required to conduct a post-approval study on the effects of the Barostim Neo system.
“After many decades of research in the field of neuromodulation, the Barostim Neo is the first device approved in the United States that uses the power of the brain and nervous system to target cardiovascular disease,” Nadim Yared, President and CEO of CVRx, said in a release. “We are thrilled to transition to the next stage of our company’s growth, shifting our focus to the successful adoption of Barostim Neo in the United States and bringing an innovative solution to chronic heart failure patients.”
“Patients with advanced heart failure have limitations of physical activity, experiencing fatigue, palpitation or shortness of breath with activity and may not benefit from standard treatments, including currently marketed drugs and devices,” director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, Dr. Bram Zuckerman, added in prepared remarks. “This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure.”