Minnesota-based CVRx has won FDA approval for the first neuromodulation device designed for the treatment of heart failure and high blood pressure.
The device, Barostim Neo, is designed to activate the body’s natural blood flow regulation to treat these conditions, and can be adjusted to meet each patient’s needs. It gained approval through the premarket (PMA) pathway, and has already received a CE mark for the same indications.
A new application for neuromodulation
Due to high costs and surgical risks, the neuromodulation market has previously focused on chronic pain and neurological disorders.
In terms of design, the Barostim Neo system mirrors other neuromodulation devices on the market. The system consists of an electrode lead (baroreceptor) attached into the carotid artery. An implantable pulse generator (IPG) is inserted under the skin and designed to electrically activate the leads, while a programmer system enables the clinician to customise therapy needs. The IPG sends electrical impulses to the baroreceptor, which senses blood flow through the carotid artery. The brain then relays signals to the heart and blood vessels, inhibiting the production of stress-related hormones and in turn reducing heart failure symptoms.
There have been previous efforts to develop neuromodulation devices for heart failure. However, these attempts have been unsuccessful in clinical trials. CVRx’s approval is based on clinical trial data from the Baroreflex Activation Therapy for Heart Failure pivotal trial (BeAT-HF). The trial, consisting of 408 patients with advanced heart failure, showed that Barostim Neo improved patients’ quality of life, their exercise capacity, and functional status.
As part of the approval process, the FDA is requiring CVRx to conduct a post-approval study. This will investigate the potential of the device to prolong life and reduce the need for patient hospitalization. GlobalData predicts the device will disrupt the neuromodulation market upon its launch.