Magnetic Resonance Conditional Labeling for Neuromodulation Device
The Barostim System, a neuromodulation device developed by CVRx to treat the symptoms of heart failure, has been approved in the United States.
Magnetic resonance (MR) conditional labeling has been approved by the Food and Drug Administration (FDA).
The Barostim neuromodulation device for treating heart failure symptoms now includes instructions for safe MRI scans of the head and lower extremities, giving heart failure patients who have Barostim extra diagnostic alternatives.
When the requirements of usage are met, all Barostim patients, including those who are already receiving Barostim therapy, can now safely undergo a 1.5T MRI.
The barostim system was created to stimulate baroreceptors, lowering the burden on the heart and allowing it to pump more efficiently, therefore improving heart failure symptoms.
When compared to the control group, those implanted with Barostim were able to walk further in a six-minute hall walk test, had a higher quality of life, and looked to have a lower rate of significant cardiovascular events, including arrhythmias.
Heart failure is a long-term disorder in which the heart muscle is unable to pump enough blood to meet the body's requirements for blood and oxygen.