investigational device exemption (IDE) approval
MINNEAPOLIS, April 29, 2013
CVRx, Inc., a private medical device company, received Food and Drug Administration (FDA) investigational device exemption (IDE) approval, allowing the company to proceed with its hypertension study
Barostim neo is designed to use the body’s own natural blood flow regulation system to treat hypertension.
The system works by electrically activating baroreceptors, the body’s natural blood pressure sensors that regulate cardiovascular function. When the Barostimneo is activated, signals are sent through neural pathways to the brain, which responds by telling the arteries to relax, the heart to slow down and the kidneys to reduce fluid in the body, lowering excessive blood pressure and workload on the heart.
http://www.cvrx.com/int/ play video