CVRx (Nasdaq:CVRX) announced today that the FDA approved magnetic resonance (MR) conditional labeling for its Barostim system.
The Barostim neuromodulation system for treating the symptoms of heart failure now includes instructions to allow for safe MRI scans of the head and lower extremities, offering heart failure patients implanted with Barostim more diagnostic options.
Minneapolis-based CVRx said in a news release that all Barostim patients, including those already receiving Barostim therapy, can now safely receive an MRI at 1.5T when conditions of use are met.
CVRx designed the Barostim system to stimulate baroreceptors, reducing the heart’s workload and helping it to pump more efficiently to improve the symptoms for heart failure patients. Studies have shown those implanted with Barostim were able to walk further in a six-minute hall walk test, have a higher quality of life and they appeared to have a reduction in the rate of serious cardiovascular events, including arrhythmias, compared to the control group.
“This is a significant milestone for CVRx, and more importantly, for the heart failure patients benefitting from our therapy,” CVRx President and CEO Nadim Yared said in the release. “These heart failure patients undergo many physical assessments. This approval expands the diagnostic imaging options available to physicians for these patients, should the need arise.”