The FDA approved a new device for people suffering from advanced heart failure who are not able to receive treatment from other devices, such as cardiac resynchronization therapy.
The Barostim Neo system developed by CVRx includes a pulse generator implanted below the collarbone with a lead attached to the carotid artery. The device delivers electrical impulses to the neck’s baroreceptor cells, which sense the flow of blood through the arteries.
Those cells then relay signals to the brain, which slows down the production of stress-related hormones and tells the heart and blood vessels to relax. The goal is to reduce the symptoms of heart failure including fatigue, shortness of breath and limited physical activity.
The FDA previously granted the device a breakthrough designation and expedited access for addressing an unmet medical need where standard therapies have failed to offer benefits to patients with no alternative treatment options.
"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," CVRx President and CEO Nadim Yared said in a statement.
According to the FDA, about 5.7 million people in the U.S. suffer from heart failure, where a weakened muscle has trouble pushing blood to the rest of the body. The Barostim Neo system was approved for patients with a regular heart rhythm and a left ventricular ejection fraction of 35% or less—far below the normal percentages of blood pumped out with each heartbeat, which typically ranges from 55% to 75%.
A randomized clinical trial included 408 heart failure patients receiving therapy, including medication, with 125 also receiving the Barostim Neo system. Those implanted with the device showed improvements in walking distances as well as other symptoms, while 102 participants saw lower levels of a heart failure biomarker, the agency said.
The FDA is also requiring CVRx to conduct a post-approval study to gauge the device’s potential in reducing hospitalizations and its effects on long-term survival.