CVRx, Inc., developer of the world’s first FDA-approved neuromodulation device to treat the symptoms of heart failure, has received U.S. FDA approval for magnetic resonance (MR) conditional labeling for its Barostim System.
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. A search of our pages is enough to tell the reader that this is an ongoing healthcare challenge that the medtech industry has been addressing for years.
CVRx is focused on the development and commercialization of Barostim™. This is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure.
Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery.The baroreceptors are natural sensors in the body that tell the nervous system how to regulate heart, kidney and vascular function. Barostim effectively reduces the heart’s workload and help it pump more efficiently. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the unwelcome symptoms.
In the BeAT-HF Study, patients who had Barostim implanted were able to walk further in a 6-minute hall walk test. They also reported better quality of life and appeared to have a reduction in the rate of serious cardiovascular events, including arrythmias, compared to the control group.
The Barostim System now includes instructions to allow for safe MRI scans of the head and lower extremities. This means heart failure patients implanted with Barostim have more diagnostic options. All Barostim System patients, including those already receiving the therapy, can safely receive an MRI at 1.5T when conditions of use are met.
Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. Moreover it has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area.
“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 patients undergo many physical assessments. This approval expands the diagnostic imaging options available to physicians for these patients, should the need arise.”
Source: Globe Newswire