FDA grants MR conditional labeling for implantable HF device
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The FDA approved magnetic resonance conditional labeling for an implantable neurostimulator HF device, allowing patients with the device to safely undergo MRI, according to a press release from CVRx.
The Barostim System (CVRx) now includes instructions to allow for safe MRI scans of the head and lower extremities, according to the release. 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," Nadim Yared, president and CEO of CVRx, said in the release. "These HF patients undergo many physical assessments. This approval expands the diagnostic imaging options available to physicians for these patients, should the need arise."
As Healio previously reported, the FDA approved the Barostim Neo System for the improvement of symptoms in patients with advanced HF who are not suited for treatment with other HF devices, such as cardiac resynchronization therapy, in August 2019.
The Barostim Neo System includes a pulse generator that is implanted below the collarbone, connected to a lead that attaches the device to the carotid artery to deliver electrical impulses to baroreceptors that sense blood flow through the carotid arteries. Once a physician tests and programs the device after implantation, the baroreceptors receive the electrical impulses and signal the brain, which then signals to the heart and blood vessels that relaxes the vessels, inhibiting the production of stress-related hormones and reducing HF symptoms.
In the BeAT-HF Study, researchers found that baroreflex activation therapy was associated with improvements in N-terminal pro-B natriuretic peptide levels, quality of life and functional outcomes in certain patients with HF with reduced ejection fraction. Patients who received a Barostim device were also able to walk further in a 6-minute hall walk test and appeared to have a reduction in the rate of serious CV, including arrythmias, compared with the control group.
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