At long last, CVRx device gets FDA approval

After years of work, Minnesota-based device firm CVRx has obtained approval from the Food and Drug Administration to sell its neurostimulation device for heart failure commercially in the United States.

CVRx, a privately owned med-tech firm in Brooklyn Park founded in 2001, says its Barostim Neo system is the first medical device approved in the U.S. that treats chronic heart failure by sending electrical impulses to the natural baroreceptors in the carotid artery in the neck.

"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 CEO Nadim Yared said in a company announcement.

Neuromodulation is a broad category of medical therapies in which pacemaker-like devices are implanted under the skin to apply electric current directly to nerves to stimulate brain activity and trigger desired physiologic changes.

CVRx specializes in applying mild current to nerve endings in the carotid artery in the neck. The company has run clinical trials in the past to see how well the system could lower blood pressure and treat heart failure. After seeing the results, the company opted in 2015 to focus on heart failure.

In May, researchers presented the results of a pivotal controlled clinical trial (PDF) in which 130 people who had been on guideline-directed medical therapy were randomized to get a Barostim Neo, while another 134 people remained on medical therapy in the company-sponsored trial.

The results showed objective and subjective improvements in CVRx' patients. Objectively, the Barostim group saw a 21% reduction in the hormone NT-proBNP, while the control group saw a 3% increase. NT-proBNP is a closely watched biomarker because increases indicate a worsening of heart failure.

Barostim patients also showed improvements in "quality of life" measurements, including a 14-point improvement over the control group in the Minnesota Living with Heart Failure Questionnaire, and a 60-meter improvement in the standardized 6-minute hall walk test.

Patients in the study were generally only eligible if they had Class III heart failure and a 35% or less ejection fraction in the left ventricle, but were not eligible for a biventricular CRT device. Such patients aren't seen as being sick enough to justify heart transplants or LVADs (left-ventricular assist devices), but their symptoms are severe enough to limit quality of life, including substantially reduced ability to exercise.