Barostim Neo® is a neuromodulation system developed by CVRx for the treatment of heart failure and hypertension. The system received CE mark from the National Standards Authority of Ireland (NSAI) in September 2014 to treat heart failure patients with an ejection fraction less than or equal to 35%.
The system label was expanded as MR Conditional in December 2014, indicating that the device can be safely used in magnetic resonance imaging (MRI) systems under provided conditions.
The system received breakthrough device designation from the US Food and Drug Administration (FDA) in June 2015. The FDA provided pre-market approval (PMA) to the device in August 2019 for patients with advanced heart failure symptoms and ineligible for cardiac resynchronisation therapy (CRT).
Barostim Neo is approved for heart failure treatment in more than 30 countries and to treat resistant hypertension in Europe, Columbia and New Zealand.
Barostim Neo is a next-generation, minimally-invasive and implantable system developed using CVRx’s proprietary technology, Barostim Therapy®. The system comprises an implantable pulse generator, a carotid sinus lead (CSL) kit, a wireless programmer system and a CSL repair kit.
The implantable pulse generator (IPG) measures 50mm-wide, 72mm-high and 14mm-thick. It encloses a battery and a circuit, which delivers activation energy to the baroreceptors placed on the right or left carotid artery. The CSL kit contains a 2mm electrode and an implant tool interface, connected to the IPG through the connector module.
The wireless programmer system enables communication with the IPG. The therapy specifications are fed into the device, while the IPG status information is collected by the programmer system.
The CSL repair kit contains the necessary materials required to repair the parts and accessories of the system.
The IPG is implanted subcutaneously below the collar bone and connected to the baroreceptors through the CSL. It sends electrical impulses to the carotid artery and activates the baroreflex, a natural mechanism of the body to maintain cardiovascular functioning.
The activation of the pathway lowers the sympathetic activity and increases parasympathetic activity to maintain the sympathovagal balance.
FDA approval for the system comes from a two-phased, multi-centre, randomised, controlled clinical trial, Baroreflex Activation Therapy® for Heart Failure (BeAT-HF). A total of 408 patients across 92 sites were enrolled to study the safety and effectiveness of the device.
Major adverse neurological and cardiac events (MANCE) and event-free rate were determined at six months to evaluate the safety of the device. The effectiveness of the device was assessed by six-minute hall walk (6MHW) based on the Minnesota Living with Heart Failure (QoL) questionnaire data and testing of N-terminal pro-brain natriuretic peptide (NT-proBNP), a prohormone related to cardiac disorder.
The first phase of the trial, the expedited phase, supported the PMA under the FDA’s Breakthrough Devices Programme. Long-term information is being collected under the ongoing second phase, the extended phase.
Patients were randomised to receive either Barostim Therapy by Barostim Neo system along with medical management or medical management alone. At the end of six months, 96.8% of the patients with Barostim Neo system plus medical management remained free from MANCE.
The device was found safe for patients with heart failure symptoms, having reduced ejection fraction. Patients demonstrated improved quality of life by 14 points according to the QoL questionnaire.
The exercise capacity of the patients improved by 60m according to the 6MHW test, while the functional status improved under New York Heart Association (NYHA) classification. The level of NT-proBNP in patients using the system also reduced significantly.
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