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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 NEO™ System may include, but are not limited to:

  • In heart failure patients: Improves physical function, quality of life, and cardiac function; 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 BAROSTIM NEO™ 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
  • 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, 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
  • 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
  • Cardiac Arrhythmias
  • Death
  • Exacerbation of Heart Failure
  • Worsening of chronic kidney disease – repeated ischemic insults superimposed on damaged kidneys could, in
    theory result in acceleration of chronic kidney disease progression, including acute kidney injury
  • Possible high potassium levels, hyperkalemia
  • Pneumothorax – collapsed lung due to the surgical procedure

*CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.

Regulatory Disclaimer

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 NEO™ Brief Summary for Physicians

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 guidelines.

Patients are contraindicated if they have been assessed to have bilateral carotid bifurcations located above the level of the mandible, baroreflex failure or autonomic neuropathy, uncontrolled symptomatic cardiac bradyarrhythmias, carotid atherosclerosis that is determined by ultrasound or angiographic evaluation greater than 50%, 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, monitor blood pressure and heart rate during Carotid Sinus Lead placement and when adjusting stimulation parameters intra-operatively, post-implantation, program the system to 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 (see “Device Interaction Testing” in Section 10), or any other potentially hazardous patient responses are observed. Do not use Magnetic Resonance Imaging (MRI) on patients implanted with the system. 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 IPG may affect the operation of other implanted devices such as cardiac defibrillators, pacemakers, or neurological stimulation systems. For patients who currently have an implanted electrical medical device, physicians must verify compatibility with the implanted device during implantation of the system. Contralateral implant of the BAROSTIM NEO IPG may help to reduce potential interactions. 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 IPG 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 NEO System should not be implanted.

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 explantation. 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 baroreflex activation may include, but are not limited to: stroke, transient ischemic attack (TIA), systemic embolization, surgical or anesthetic complications, infection, wound complications, arterial damage, pain, 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.