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
  • In resistant hypertension patients: Lowers blood pressure, regresses left ventricular hypertrophy (as evidenced by left ventricular mass index reduction), improves quality of life, minimizes  other symptoms, and reduces cardiovascular events
  • In chronic kidney disease patients: Maintains renal function; lowers renal sympathetic nerve activity; suppresses neurohormonal activation; reduces renal artery stiffness and blood pressure

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 failure
  • 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

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