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Important Safety & Regulatory Information

Benefit risk analysis

Reported/Theoretical Benefits

Reported and potential benefits for patients/subjects treated with the BAROSTIM System may include, but are not limited to:

  • In heart failure patients: Improves hear failure functional status, six-minute hall walk, and quality of life; reduces hospitalization rates

Reported/Theoretical Harms and Hazards

Patients/Subjects implanted with the BAROSTIM NEO™ System are anticipated to be exposed to operative and post-operative risks similar to related surgical procedures involving the neck and chest. The hazards and potential hazards may include, but are not limited to:

  • Stroke – a neurological deficit lasting more than 24 hours or less than 24 hours with a brain imaging study showing infarction
  • Transient ischemic attack (TIA) – a neurological deficit lasting less than 24 hours without evidence of permanent cerebral infarction
  • Systemic embolization – downstream obstruction of a blood vessel by migration of loosened intravascular plaque or clot
  • Surgical or anesthetic complications
  • Infection – the need for antibiotics or possible removal of the System
  • Wound Complication – including hematoma (i.e. bruising and/or swelling)
  • Arterial damage – including carotid artery rupture or hemorrhage (sudden and significant blood loss at a site of blood vessel rupture that may require reoperation or transfusion)
  • Pain – an unpleasant sensory experience
  • Transient, Temporary, or Permanent Nerve Damage/Stimulation – including injury to or stimulation of Cranial, Marginal Mandibular, Glossopharyngeal, Recurrent Laryngeal, Vagus and Hypoglossal Nerves (numbness in head and neck, facial palsy/paralysis, altered speech, altered sense of taste, respiratory constriction, stertorous breathing, excessive salivation, dry cough, vomiting and/or regurgitation, altered sensory and motor function of tongue, altered sensory function of pharynx and oropharynx, altered sensation in external auditory canal), stimulation of extravascular tissue (muscle twitching, pain, tingling, oral sensations)
  • Hypotension – a decrease in systolic and diastolic blood pressure below normal levels that may result in dizziness, fainting, and/or falls
  • Hypertensive crisis – uncontrolled rise in blood pressure
  • Respiratory – including low oxygen saturation, respiratory distress, shortness of breath
  • Exacerbation of heart failure
  • Cardiac arrhythmias – A condition where the heart beats too fast, too slow, or irregularly
  • Tissue erosion/IPG migration – movement of device resulting in need for reoperation
  • Injury to baroreceptors – an injury that results in baroreflex failure
  • Fibrosis – replacement of normal tissue by the ingrowth of fibroblasts and the deposition of connective tissue
  • Allergic Reaction
  • General injury to user or patient – may be due to surgical procedure, device use, or interaction with other devices
  • Need for reoperation – operation to explant/replace IPG or CSLs due to tissue damage, infection, and/or device
  • Secondary operative procedure – an increase in the complexity and risk of secondary operative procedures of the neck due to scar tissue and the presence of prosthetic material implanted for this device
  • Death

Regulatory Disclaimer

Important Safety Information

CAUTION: Federal law restricts this device to sale by or on the order of a physician.  See Instructions for Use 900133-001 for a complete instruction for use and a description of indications, contraindications, warnings, precautions and adverse events.
Barostim™ Brief Summary for Physicians

Barostim™ Brief Summary for Physicians

The Barostim System is indicated for patients who are NYHA Class III or Class II (who had a recent history of Class III) despite treatment with guideline-directed medical therapies (medications and devices), have a left ventricular ejection fraction of ≤ 35%, and a NT-proBNP <1600 pg/ml. Barostim delivers Baroreflex Activation Therapy for improvement of patients’ heart failure functional status, six-minute hall walk, and quality of life.

Patients are contraindicated if they have bilateral carotid bifurcations located above the level of the mandible, baroreflex failure or autonomic neuropathy, uncontrolled symptomatic cardiac bradyarrhythmias, carotid artery stenosis greater than 50% caused by atherosclerosis, as determined by ultrasound or angiographic evaluation, ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation, known allergy to silicone or titanium.

Warnings include:  only trained physicians may use this system, prescribing physicians should be experienced in the diagnosis and treatment of heart failure and should be familiar with the use of this system, blood pressure and heart rate should be monitored during Carotid Sinus Lead placement and when adjusting stimulation parameters intra-operatively, system programming post-implantation, should avoid the following:  heart rate falls below 50 beats per minute (BPM), or systolic pressure falls below 90 mmHg, or diastolic blood pressure falls below 50 mmHg, or problematic adjacent tissue stimulation is noted, or undesirable interaction indicated by monitoring of any other implanted electrical device, or any other potentially hazardous patient responses are observed. For patients who currently have an implanted electrical medical device, physicians must verify compatibility with the implanted device during implantation of the system as well as whenever settings are changed in either implant. Interactions are more likely in devices that contain a sensing function, such as an implantable cardiac defibrillator or pacemaker.  If an interaction is observed, the Barostim NEO and NEO2 should be programmed to reduced therapy output settings in order to eliminate the interaction.  If necessary, change settings in the other implant only if the changes are not expected to negatively impact its ability to perform its prescribed therapy.  During the implant procedure, if device interactions cannot be eliminated the Barostim System should not be implanted. Improper system implantation could result in serious injury or death. Do not use diathermy therapy including shortwave, microwave, or therapeutic ultrasound diathermy on patients implanted with the system.  Patients should be counseled to stay at least 15 cm (6 inches) away from devices with strong electrical or magnetic fields such as strong magnets, loudspeaker magnets, Electronic Article Surveillance (EAS) system tag deactivators, arc welders, induction furnaces, and other similar electrical or electromechanical devices. This would include not placing items such as earphones in close proximity to the implanted pulse generator. The system may affect the operation of other implanted devices such as cardiac defibrillators, pacemakers, or neurological stimulation systems.

Precautions include:  the system should be implanted and programmed carefully to avoid stimulation of tissues near the electrode or in the area of the IPG pocket.  Such extraneous stimulation could involve the following:  the regional nerves, causing laryngeal irritation, difficulty swallowing, or dyspnea, the cervical musculature, causing intermittent contraction, skeletal muscles, causing intermittent contraction around the IPG pocket.  Proper sterile technique during implantation should be practiced and aggressive pre-operative antibiotics are recommended.  Infections related to any implanted device are difficult to treat and may necessitate device explanation.

It is anticipated that subjects will be exposed to operative and post-operative risks similar to related surgical procedures involving the neck and/or a pacemaker implant.  These risks and potential risks of chronic device based Barostim may include, but are not limited to:  stroke, transient ischemic attack (TIA), systemic embolization, surgical or anesthetic complications, infection, wound complications, arterial damage, pain, transient, temporary or permanent nerve damage/stimulation, hypotension, hypertensive crisis, respiratory, exacerbation of heart failure, cardiac arrhythmias, tissue erosion/IPG migration, injury to baroreceptors, fibrosis, allergic reaction, general injury to user or patient, need for reoperation, secondary operative procedure, and death.  Patients implanted with the system may receive Magnetic Resonance Imaging (MRI) only when all MR Conditional safety parameters are met as listed in the instructions for use.

CVRx, Barostim, BAT, Barostim NEO, Barostim NEO2, BATwire, Outsmart the heart, and Barohub are all trademarks of CVRx, Inc. © 2024 CVRx, Inc.  All rights reserved.  All other trademarks are property of their respective owners.

For a list of all potential benefits and risks go to

For a list of all applicable patents, see