News | Magnetic Resonance Imaging (MRI) | May 09, 2022

CVRx Receives MR-conditional Labeling Approval for its Barostim Heart Failure System

Heart failure patients implanted with Barostim can now receive conditional MRI scans

Heart failure patients implanted with Barostim can now receive conditional MRI scans

May 9, 2022 — CVRx, Inc., developer of the world’s first FDA-approved neuromodulation device to treat the symptoms of heart failure, has received U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR) conditional labeling for its Barostim System.

The Barostim System now includes instructions to allow for safe MRI scans of the head and lower extremities, meaning heart failure patients implanted with Barostim have more diagnostic options. All Barostim System patients, including those already receiving Barostim therapy, can safely receive an MRI at 1.5T when conditions of use are met.

"This is a significant milestone for CVRx, and more importantly, for the heart failure patients benefitting from our therapy," said Nadim Yared, President and CEO of CVRx. "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."

Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body’s needs for blood and oxygen. Barostim works by stimulating baroreceptors – natural sensors in the body that tell the nervous system how to regulate heart, kidney and vascular function. These effects reduce the heart’s workload and help it pump more efficiently, helping to improve the symptoms for patients with heart failure. In the BeAT-HF Study, patients who had Barostim implanted were able to walk further in a 6-minute hall walk test, have a higher quality of life and appeared to have a reduction in the rate of serious cardiovascular events, including arrythmias, compared to the control group.

For more information: www.cvrx.com


Related Content

News | Heart Failure

March 21, 2023 — Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac and ...

Home March 21, 2023
Home
News | Heart Failure

March 21, 2023 — CVRx, Inc., a commercial-stage medical device company focused on developing, manufacturing and ...

Home March 21, 2023
Home
News | Heart Failure

March 5, 2023 — Doctors who received customized electronic health record (EHR) alerts for specific patients were 2.5 ...

Home March 05, 2023
Home
News | Heart Failure

March 4, 2023 - Lexicon Pharmaceuticals, Inc. announced new analyses of results from the SOLOIST-WHF Phase 3 outcomes ...

Home March 04, 2023
Home
News | Heart Failure

March 3, 2023 — Researchers may be able to predict cardiovascular disease – such as atrial fibrillation and heart ...

Home March 03, 2023
Home
News | Heart Failure

February 24, 2023 — Abiomed, Inc., part of Johnson & Johnson MedTech[1], announced that results from a study on Impella ...

Home February 24, 2023
Home
News | Heart Failure

February 23, 2023 — Lexicon Pharmaceuticals, Inc. announced the upcoming presentation of new analyses of results from ...

Home February 23, 2023
Home
News | Heart Failure

February 22, 2023 — CVRx, Inc., a commercial-stage medical device company focused on developing, manufacturing and ...

Home February 22, 2023
Home
News | Heart Failure

February 2, 2023 — Technology is continuously evolving, and so is the approach taken by transplant cardiologists at ...

Home February 02, 2023
Home
News | Heart Failure

January 25, 2023 — Adults living in rural areas of the United States have a 19% higher risk of developing heart failure ...

Home January 25, 2023
Home
Subscribe Now