CVRx announced that the U.S. Food and Drug Administration (FDA) has given MRI-conditional labeling to the company's Barostim implantable device for heart failure patients.
Now, the system includes instructions allowing MRI scans to be performed of the head and lower extremities of patients implanted with Barostim. When conditions of use are met, Barostim patients, including those already receiving Barostim therapy, can safely receive an MRI scan at 1.5 tesla.
Barostim works by stimulating baroreceptors, which reduce the heart's workload and help it pump more efficiently, helping to improve symptoms for patients with heart failure.