The World’s First Neuromodulation Device for the Treatment of Heart Failure
BAROSTIM NEO is designed to use the Brain to Treat the Heart
BAROSTIM NEO is designed to electrically activate the baroreflex, the body’s main cardiovascular reflex, signaling the brain to regulate cardiovascular function.
BAROSTIM THERAPY activates baroreceptors in the wall of the carotid artery and stimulates the afferent and efferent pathways of the autonomic nervous system. The brain responds to the therapy by modulating efferent pathways, to relax blood vessels, slow the heart rate and reduce fluid in the body via improved kidney function.
Restoring Sympatho-Vagal Balance
BAROSTIM THERAPY is the only treatment that reduces sympathetic activity while restoring parasympathetic activity.
The increase in parasympathetic tone and decrease in sympathetic drive results in the restoration of autonomic balance, which can improve cardiac structure and function.
FDA's Breakthrough Device
Designed to address a significant unmet medical need in heart failure, the BAROSTIM NEO was one of the first therapies to receive the FDA’s coveted Breakthrough Device Designation. This distinction is reserved for unique therapies that are intended to treat a life-threatening or irreversibly debilitating disease where there is no available treatment alternative.
BAROSTIM NEO is completely subcutaneous, without hardware in the heart or vasculature.
A 2mm electrode is sutured to the carotid artery and connected to the IPG, electrically activating the baroreceptors.
Implantable Pulse Generator (IPG)
A highly powerful, IPG is inserted under the collar bone, stimulating approximately 40 times more frequently than a pacemaker.
Wireless Programmer System
Wireless sessions are straight-forward and require minimal programming and results in no additional data collection burden on practitioners or staff.
BAROSTIM NEO Placement Procedure
Implanting this device is, I think, a lot simpler compared to implanting a device that requires putting wires in the heart.
The placement of the BAROSTIM NEO requires a minimally-invasive procedure under general anesthesia and can be done in an EP or Cath Lab as an outpatient procedure.
An incision is made in the neck and the carotid artery is exposed. Lead is connected to the IPG. Lead is mapped and sutured. Lead is disconnected from the IPG.
A pocket is created for the IPG and tunneling to the lead is performed. A strain relief loop is created and the lead is connected to the IPG.
The IPG is secured and incisions are closed.
Indication for Use in the United States
The BAROSTIM NEO System is indicated for the improvement of symptoms of heart failure—quality of life, six-minute hall walk and functional status—for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ ESC guideliness.12
A Solution for the 59%
59%2-11 of patients with NYHA Class II or III and
LVEF < 35% are not eligible for CRT.
BAROSTIM NEO is indicated for the 59%.
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BAROSTIM NEO™ Brief Summary for Physicians
CAUTION: Federal law restricts this device to sale by or on the order of a physician. See System Reference Guide 900120-001 for a complete instruction for use and a description of indications, contraindications, warnings, precautions and adverse events.