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

June 29, 2022 — A spiral wave of electrical activity in the heart can cause catastrophic consequences. One spiral wave ...

Home June 29, 2022
Home
News | Heart Failure

June 29, 2022 — Adult survivors of cancer have a higher risk of heart failure and other cardiovascular diseases (CVD) ...

Home June 29, 2022
Home
News | Heart Failure

June 29, 2022 — While lower vertebrates can repair their adult hearts after a heart attack, mammals — including humans — ...

Home June 29, 2022
Home
News | Heart Failure

June 27, 2022 — Results from one of the largest global studies of atrial fibrillation (AFib) procedures show that the ...

Home June 28, 2022
Home
News | Heart Failure

June 22, 2022 — Recommendations on how to use gene testing to prevent sudden cardiac death in athletes and enable safe ...

Home June 22, 2022
Home
News | Heart Failure

June 22, 2022— Researchers at The Ohio State University Wexner Medical Center and College of Medicine have developed a ...

Home June 22, 2022
Home
News | Heart Failure

June 20, 2022— Marc Chatzky may not feel like a cardiac pioneer, but he is, at least in South Florida. The Deerfield ...

Home June 20, 2022
Home
News | Heart Failure

June 10, 2022 — Individuals with diabetes display a substantially increased risk of disease in left-sided heart valves ...

Home June 10, 2022
Home
News | Heart Failure

June 9, 2022 — Memorial Regional Hospital recently entered elite company, becoming just the fourth hospital in the ...

Home June 09, 2022
Home
News | Heart Failure

June 3, 3033 — Esperion announced findings from a real-world analysis of more than 400,000 patients at high-risk for ...

Home June 03, 2022
Home
Subscribe Now